FDA Adverse Event
Injury
Summary report: N
ENTRUST VR
MDR report key: 2951485
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01545
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 27, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016/S046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED; 1 - POR FOR CRITICAL RAM PARITY ERROR, ADDR=17C3, DATA=E6 ON (B)(6) 2011 03:00:23. 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 03:00:23. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO MEDICAL JUDGEMENT. THE DEVICE WAS RETURNED, PERFORMANCE INFORMATION WAS ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56559 | ENTRUST VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154VRC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | Hospitalization| R | 6949 IMPLANTABLE TACHY LEAD |