FDA Adverse Event
Malfunction
Summary report: N
EDP 30/S
MDR report key: 2123214
·
Received October 28, 2008
Report
- Report Number
- 1028232-2008-01279
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IN (B)(6) 2008, A SUDDEN ASYSTOLE OF THE PT WAS REPORTED. IN RESPONSE, THE BATTERY WAS EXCHANGED. THERE WAS NO IMPROVEMENT. THE EVENT DATE WAS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDP 30/S | EXTERNAL PACEMAKER | LWS | BIOTRONIK GMBH AND CO. | 123828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death| R |