FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1936056
·
Received December 10, 2010
Report
- Report Number
- 3006630150-2010-02055
- Event Type
- Injury
- Date Received
- December 10, 2010
- Date of Event
- November 19, 2010
- Report Date
- November 19, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
DURING A LEAD REVISION PROCEDURE, THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM AS THE PT WAS EXPERIENCING CHARGING DIFFICULTIES. THE PHYSICIAN DID NOT BELIEVE, THERE WAS ANYTHING WRONG WITH THE DEVICE. THE PT WAS DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | (B)(4)| MODEL#: SC-8216-50| ARTISAN 2X8 LIM, 50CM: |