FDA Adverse Event
Injury
Summary report: N
QUATTRODE LEAD WIDE SPACED, 60 CM
MDR report key: 2091635
·
Received April 28, 2011
Report
- Report Number
- 1627487-2011-00586
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- GZB
- PMA / PMN Number
- K072462
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
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 3. REFERENCE MFR REPORT #S 1627487-2011-00585 AND 1627487-2011-00587. THE PATIENT RECEIVED AN SCS SYSTEM FOR FLANK PAIN INCLUDING AN IPG, FOUR PERCUTANEOUS LEADS AND A LEAD EXTENSION ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT'S SCS SYSTEM WAS REMOVED DUE TO ALLEGATIONS OF INEFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRODE LEAD WIDE SPACED, 60 CM | SPINAL CORD STIMULATION LEAD | GZB | ST JUDE MEDICAL - NEUROMODULATION DIVISION | 3166 | 2847759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |