FDA Adverse Event
Malfunction
Summary report: N
ENTRUST VR
MDR report key: 2201645
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-03786
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- February 24, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- 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
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POWER ON RESET - POWER ON RESET PARAMETERS 1 - POR FOR CRITICAL RAM PARITY ERROR, ADDR = 127B, DATA = 04, ON (B)(6) 2011 07:56:30. ONE - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 07:56:30.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD POWER ON RESET. THE DEVICE REMAINS IN USE. 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 VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154VRC | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | 6945 IMPLANTABLE TACHY LEAD |