FDA Adverse Event
Injury
Summary report: N
QUATTRODE
MDR report key: 2894875
·
Received December 20, 2012
Report
- Report Number
- 1627487-2012-10686
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED INVALID IMPEDANCES WERE IDENTIFIED ((B)(6)). INTRA-OPERATIVE TESTING CONFIRMED THE ISSUE WAS WITH THE SCS LEAD. THE LEAD WAS EXPLANTED AND REPLACED WHICH RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3146 | 3719693 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |