FDA Adverse Event
Injury
Summary report: N
COROX OTW 75-UP STEROID
MDR report key: 1231653
·
Received November 14, 2008
Report
- Report Number
- 1028232-2008-01439
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- July 24, 2008
- Report Date
- September 16, 2008
- Manufacturer
- BIOTRONIK GMBH & CO.
- Product Code
- MRM
- PMA / PMN Number
- P050023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BOTH THE MECHANICAL AND THE ELECTRICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WERE SCRUTINIZED, WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECS. THE DAMAGED OUTER INSULATION WAS MOST LIKELY DUE TO THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MFG PROBLEM.
Description of Event or Problem · 1
PER STUDY ADVERSE EVENT FORM, THIS LEAD WAS EXPLANTED BECAUSE IT HAD DISLODGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROX OTW 75-UP STEROID | LV LEAD | MRM | BIOTRONIK GMBH & CO. | 346542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |