FDA Adverse Event
Injury
Summary report: N
ENTRUST AT
MDR report key: 2813642
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02509
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- January 3, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- Z-1172-2009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND THE ANALYSIS WAS INCONCLUSIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW UP IT WAS IMPOSSIBLE TO INTERROGATE THE DEVICE DUE TO NO TELEMETRY AND NO OUTPUT. IT WAS ALSO REPORTED THAT THE DEVICE IS UNDER ADVISORY FOR POTENTIAL RAPID BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST AT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | D154ATG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |