FDA Adverse Event
Injury
Summary report: N
CINCH ANCHOR
MDR report key: 2921989
·
Received January 4, 2013
Report
- Report Number
- 1627487-2013-02025
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- October 9, 2012
- Report Date
- December 11, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- K081208
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02613.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5970 | CINCH ANCHOR | SCS ANCHOR | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 1194 | 3624982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | SCS IPG: MODEL 3716| IMPLANT DATE: |