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ENTERRA

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Most Common Enterra Reports to the FDA

What are the most common Enterra reports to the FDA?

Inappropriate Shock
82
Device Operates Differently Than Ex...
59
Explanted
56
No Information
51
Unknown (for Use When The Device Pr...
42
No Known Device Problem
35
Migration Of Device Or Device Compo...
26
Electro-magnetic Interference (emi)
23
High Impedance
18
Replace
18
Implant, Repositioning Of
15
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Premature Discharge Of Battery
15
Device Remains Implanted
10
Implant, Reprogramming Of
9
Shock, Electrical
8
Device Operational Issue
6
Electro-magnetic Interference (emi)...
6
Fracture
6
Impedance Issue
6
Material Erosion
6
Dislodged Or Dislocated
5
Low Battery
5
Wire(s), Breakage Of
5
Device Inoperable
4
Low Impedance
4
Battery Issue
3
Break
3
Communication Or Transmission Issue
3
Detachment Of Device Component
3
Electronic Property Issue
3
Malposition Of Device
3
Twisting
3
Crack
2
Device Stops Intermittently
2
Disconnection
2
Failure To Interrogate
2
Human Factors Issue
2
Implant, Removal Of
2
Lead(s), Breakage Of
2
Looping
2
Malfunction
2
Other (for Use When An Appropriate ...
2
Battery Impedance Issue
1
Coiled
1
Component(s), Broken
1
Defective Component
1
Device Or Device Fragments Location...
1
Device, Or Device Fragments Remain ...
1
Dislodged
1
Elective Replacement
1
Failure To Adhere Or Bond
1
Intermittent Shock
1
Loose
1
Loose Or Intermittent Connection
1
Material Perforation
1
Material Twisted
1
No Code Available
1
Positioning Issue
1
Repair
1
Residue After Decontamination
1
Steering Wire Problem
1
Stretched
1
Tipover
1
Unintended Movement
1
Unit Inactivated
1

Devices Similar to Enterra

Enterra Scientific Publications

What Enterra safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Enterra. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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