FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1870239
·
Received October 11, 2010
Report
- Report Number
- 3006630150-2010-01725
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- May 1, 2010
- Report Date
- September 14, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S STIMULATION STOPPED WORKING. IT WAS DISCOVERED THAT CONTACT 6, AND 9-16 WERE ALL SHOWING CONSISTENTLY HIGH IMPEDANCES. X-RAYS REVEALED A POTENTIAL LEAD FRACTURE AT THE TENSION LOOP PROXIMAL TO THE ANCHORING SITE. THE PHYSICIAN RECOMMENDED A PADDLE LEAD REPLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN REPLACED THE FRACTURED LEAD AND CHOSE TO REPLACE THE IPG. THE IPG WAS WORKING PROPERLY. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8120-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |