FDA Adverse Event
Injury
Summary report: N
QUATTRODE LEAD 3/4 MM, 30 CM
MDR report key: 2210495
·
Received August 10, 2011
Report
- Report Number
- 1627487-2011-07035
- Event Type
- Injury
- Date Received
- August 10, 2011
- Date of Event
- July 12, 2011
- Report Date
- August 8, 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
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 1 OF 2. REFERENCE MFR REPORT 1627487-2011-07037. THE PT RECEIVED A SCS SYSTEM. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT IS RECEIVING A SHOCKING SENSATION WHEN SHE MOVES HER HEAD. THE DOCTOR IS PLANNING ON TAKING X-RAYS AND POTENTIALLY SCHEDULE A REVISION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRODE LEAD 3/4 MM, 30 CM | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3143 | 25962 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | IMPLANTED:| SCS IPG: MODEL 3716 |