FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1924567
·
Received December 7, 2010
Report
- Report Number
- 3006630150-2010-02087
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 12, 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR ANALYSIS AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PT'S PRECISION SYSTEM WAS EXPLANTED DURING A LEAD REVISION PROCEDURE. THE INITIAL REASON FOR THE PROCEDURE WAS LEAD MIGRATION AFTER THE PT HAD FALLEN, BUT THE PHYSICIAN NOTICED THAT THE PT'S POCKET WAS IRRITATED, SO HE DECIDED TO EXPLANT THE ENTIRE SYSTEM. NO INFECTION WAS PRESENT. THE PT WAS PRESCRIBED PREVENTATIVE ANTIBIOTICS AND IS REPORTEDLY DOING WELL.
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 | 64 YR | Required Intervention | ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| SERIAL # (B)(4) AND (B)(4)| MODEL # SC-2218-50 |