FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4136
MDR report key: 1142724
·
Received August 26, 2008
Report
- Report Number
- 1028232-2008-01027
- Event Type
- Injury
- Date Received
- August 26, 2008
- Date of Event
- June 23, 2008
- Report Date
- July 25, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFO THAT DURING ATTEMPTED LEAD IMPLANT, THIS LEAD CAUSED A PERFORATION IN THE HEART. THIS LEAD WAS REPOSITIONED AND THE PT WAS STABILIZED. AFTER THIS EVENT, THE PT WAS REPORTEDLY STABLE AND TO DATE, NO OTHER ADVERSE PT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS 4136 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 358754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |