FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 2033505
·
Received March 24, 2011
Report
- Report Number
- 1627487-2011-00400
- Event Type
- Injury
- Date Received
- March 24, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION DIV.
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00408. THE PT WAS IMPLANTED WITH DUAL PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS UNABLE TO INCREASE THE AMPLITUDE FOR HER STIMULATION VIA THE PROGRAMMER. A DIAGNOSTIC TEST WAS PERFORMED; HOWEVER, NO IMPEDANCE ISSUES WERE OBSERVED. A SUBSEQUENT X-RAY REVEALED A VISUAL ANOMALY WITH THE LEADS NEAR THE ANCHOR SITE. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RECTIFY THIS MATTER; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE LEAD KIT, 60CM LENGTH | SPINAL CORD STIMULATION LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION DIV. | 3186 | 3071333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | IPG LEAD ANCHOR: MODEL 1192| IMPLANT: |