FDA Adverse Event
Malfunction
Summary report: N
ENTRUST VR
MDR report key: 2207423
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04911
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- June 5, 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 (POR) PARAMETERS WERE NOTED AS ONE POR FOR CRITICAL RAM PARITY ERROR, ADDR=1381, DATA=8C, OCCURRED ON (B)(4)-2011 21:55:06. IT WAS ALSO NOTED THAT ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR OCCURRED ON (B)(4)-2011 21:55:06.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE IS STILL 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 | 75 YR | Other | 6949 IMPLANTABLE TACHY LEAD |