FDA Adverse Event
Malfunction
Summary report: N
OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD
MDR report key: 2182217
·
Received July 7, 2011
Report
- Report Number
- 1627487-2011-03225
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 8, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- 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
THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT HAS NO STIMULATION AFTER HER FIRST PHYSICAL THERAPY SESSION. THE SJM REP CHECKED IMPEDANCE AND FOUND THAT ALL CONTACTS WERE NOW INVALID. THE PT WILL BE SCHEDULED FOR A REVISION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3186 | 3166289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT:| SCS ANCHOR: MODEL 1192| IMPLANT: |