FDA Adverse Event
Injury
Summary report: N
DUAL 4 EXTENSION
MDR report key: 2251524
·
Received September 14, 2011
Report
- Report Number
- 1627487-2011-05145
- Event Type
- Injury
- Date Received
- September 14, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 16, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS: THE PRODUCT WAS RETURNED COMPLETE. BOTH OF THE LEAD EXTENSIONS DID NOT HAVE VISUAL ANOMALIES. ONE OF LEAD EXTENSIONS FAILED FUNCTIONAL TESTING DUE TO CHANNEL 4 BEING OPEN. 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 2 OF 2. REF MFR REPORT#: 1627487-2011-05141.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL 4 EXTENSION | SPINAL CORD STIMULATION LEAD EXTENSION | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3346 | 3126671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention | IMPLANTED:| IMPLANTED:| SCS LEAD EXTENSIONS: MODEL 3346 (2)| SCS IPG: MODEL 3716| IMPLANTED:| SCS LEADS: MODEL 3169 (4) |