FDA Adverse Event
Injury
Summary report: N
EXTENSION, DUAL 4 CHANNEL 10CM
MDR report key: 2030878
·
Received March 22, 2011
Report
- Report Number
- 1627487-2011-00379
- Event Type
- Injury
- Date Received
- March 22, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
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
DEVICE 3 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00377 AND 1627487-2011-00378. THE PT WAS IMPLANTED WITH A THORACIC SCS SYSTEM ON (B)(6) 2010, CONSISTING OF AN IPG, SURGICAL LEAD, AND LEAD EXTENSION. IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO THE PT'S COMPLAINT OF PAIN AT THE IPG AND LEAD IMPLANT SITES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTENSION, DUAL 4 CHANNEL 10CM | SPINAL CORD STIMULATION EXTENSION | LGW | ST. JUDE MEDICAL - NEUROMODULATION DIVISION | 3341 | 2879581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |