FDA Adverse Event
Malfunction
Summary report: N
PROTOS DR/CLS
MDR report key: 2052493
·
Received March 15, 2011
Report
- Report Number
- 1028232-2011-00514
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
UPON INTERROGATION, PROGRAMMER DISPLAYED "EXCESSIVE CURRENT DRAIN" NOTIFICATION. RECOMMENDED EXPLANT. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. THIS DEVICE HAS MET LONGEVITY AND WAS EXPLANTED ON (B)(6) 2011. DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTOS DR/CLS | PACEMAKER | DXY | BIOTRONIK SE & CO. KG | 122300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |