FDA Adverse Event
Injury
Summary report: N
DUAL EXTENSION
MDR report key: 4112996
·
Received September 17, 2014
Report
- Report Number
- 1627487-2014-26751
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- August 25, 2014
- Report Date
- August 25, 2014
- Manufacturer
- ST JUDE MED - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- 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 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
DEVICE #1 OF 5. REFERENCE MFR REPORT: 26752, 26753, 26754, 26759. IT WAS REPORTED THE PT IS EXPERIENCING A SHOCKING SENSATION AT THE IPG SITE WHEN HE LEANS BACKWARDS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575261 | DUAL EXTENSION | SCS EXTENSION | GZB | ST JUDE MED - NEUROMODULATION | 3341 | 4135373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | IMPLANT DATE:| SCS ANCHOR, MODEL 1194 |