FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 2973730
·
Received December 21, 2007
Report
- Report Number
- 2029203-2007-05059
- Event Type
- Injury
- Date Received
- December 21, 2007
- Date of Event
- November 30, 2007
- Report Date
- November 30, 2007
- Manufacturer
- ADVANCED BIONICS CORP.
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
DURING THE TRIAL IMPLANT PROCEDURE, THE PT WAS NOT GETTING ENOUGH AIR. THE SURGEON EXPLANTED THE LEADS AND ABORTED THE SURGERY. THE PT HAS SINCE BEEN RE-TRIALED AND IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR LEAD | LGW | ADVANCED BIONICS CORP. | SC-2208-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | EXPLANTED| (B)(4) |