FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 1031280
·
Received April 18, 2008
Report
- Report Number
- 1028232-2008-00372
- Event Type
- Injury
- Date Received
- April 18, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 18, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE JOE WITTE. PER THE OOS, IN THE POST OP CHECK, THIS PT HAD INTERMITTENT LOSS OF CAPTURE AND TOTAL LOSS OF SENSING WITH THE ATRIAL LEAD AND TOTAL LOSS OF CAPTURE WITH THE VENTRICLE LEAD. THE NEXT DAY, X-RAYS REVEALED THE V LEAD TO BE DISLODGED. IT WAS REPOSITIONED; HOWEVER, THE SENSING AND CAPTURE ISSUES REMAINED. THE PHYSICIAN ELECTED TO REPLACE BOTH LEADS WITH MEDTRONIC ACTIVE FIXATION LEADS. THE PHYSICIAN REQUESTED AN ANALYSIS OF THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 45 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |