FDA Adverse Event
Malfunction
Summary report: N
ENTRUST AT
MDR report key: 1792419
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03254
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- May 5, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
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. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THAT ON (B)(6)2010 AT 05:31:38, THE DEVICE RECORDED A CRITICAL RAM PARITY ERROR POR (POWER ON RESET).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CARELINK TRANSMISSION WAS RECEIVED AN ELECTRICAL RESET WAS NOTED FOR CRITICAL RAM PARITY ERROR. TECHNICAL SERVICES INDICATED THAT THIS WAS A NON-CRITICAL MEMORY ERROR. THE DEVICE IS 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 AT | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154ATG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other | 6948 IMPLANTABLE TACHY LEAD| 5594 IMPLANTABLE PACING LEAD |