FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1021220
·
Received March 28, 2008
Report
- Report Number
- 2029203-2008-00181
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- March 1, 2008
- Report Date
- February 27, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED PRODUCTS, WERE DISCARDED BY THE MEDICAL FACILITY, AND WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
SHORTLY AFTER A TRIAL PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO PAIN AND TREATED WITH MEDICATION. THE PATIENT ALSO REPORTED WEAKNESS IN THE RIGHT ARM AND LEG. THE PHYSICIAN DECIDED TO EXPLANT THE RIGHT LEAD. IT WAS DETERMINED THAT THE LEAD WAS PLACED SEVERELY ANTERIOR DUE TO AN EXCESS AMOUNT OF SCAR TISSUE. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR LEAD | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2208-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | EXPLANTED:| SC-2208-50 |