ENTRUST AT
Report
- Report Number
- 6000144-2012-06432
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- Z-1172-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS HEARING AN ALARM BUT INDICATED THAT IT WAS DIFFERENT FROM THE DEMONSTRATED DEVICE TONES. WHEN THE DEVICE WAS INTERROGATED, NO ALARM HAD BEEN NOTED TO BE TRIGGERED. THE DEVICE WAS NOTED TO BE APPROACHING ELECTIVE REPLACEMENT INDICATOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR AND WAS REMOVED AND REPLACED.
THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR AND WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST AT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154ATG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |