FDA Adverse Event
Malfunction
Summary report: N
SOLOX SLX 85/15 BP
MDR report key: 1170350
·
Received September 12, 2008
Report
- Report Number
- 1028232-2008-01083
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- April 3, 2008
- Report Date
- August 12, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FULL PMA CODE DOES NOT FIT IN THE SPACE PROVIDED, THEREFORE IT WILL BE ADDED.
Description of Event or Problem · 1
THIS LEAD WAS RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. PER FACILITY, THIS LEAD WAS REMOVED BECAUSE IT WAS NOT SENSING R-WAVES AND ONLY SENSING SOME P-WAVES. THIS DEVICE WAS ONLY PACING AT 6 VOLTS AND CAUSING DIAPHRAGMATIC STIMULATION. THIS LEAD WAS REPLACED WITH A COMPETITOR'S LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLOX SLX 85/15 BP | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 333902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization |