FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD
MDR report key: 2133597
·
Received June 16, 2011
Report
- Report Number
- 1627487-2011-02827
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- May 19, 2011
- Report Date
- May 19, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL: RESULTS: LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN. 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 # 1627487-2011-02828. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2006. IT WAS REPORTED THAT THE PT'S LEAD WAS REPLACED DUE TO A LEAD FRACTURE. THE ISSUE WAS RESOLVED AFTER THE REVISION PROCEDURE. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE LEAD | SPINAL CORD STIMULATION LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 56443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention | IMPLANTED:| SCS IPG: MODEL UNK |