FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1346136
·
Received March 18, 2009
Report
- Report Number
- 2029203-2009-00433
- Event Type
- Injury
- Date Received
- March 18, 2009
- Date of Event
- October 27, 2008
- Report Date
- February 19, 2009
- 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
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT HAD THEIR PRECISION SYSTEM EXPLANTED DUE TO INFECTION. THE PATIENT PRESENTED WITH PAIN AT THE BACK OF THE NECK WHERE THE ELECTRODES WERE IMPLANTED (OCCIPITAL ELECTRODES). A BLOOD CULTURE WAS TAKEN CONFIRMING INFECTION (STAPHYLOCOCCUS AUREUS) AND THE PHYSICIAN PRESCRIBED ANTIBIOTICS. IN 2008, THE PATIENT HAD THE LEADS AND LEAD EXTENSIONS REMOVED. THE INFECTION DID NOT CLEAR, AND THE IPG WAS EXPLANTED AT ABOUT 11 DAYS LATER. THE PATIENT WAS HOSPITALIZED FOR THE EXPLANT, AND RELEASED THREE DAYS POST-PROCEDURE. THE PATIENT HAS REPORTEDLY RECOVERED FROM THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2138-50T | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | MODEL #: SC-2138-50T| LINEAR TRIAL LEAD| LEAD EXTENSION| IMPLANTABLE PULSE GENERATOR| MODEL #: SC-3138-55| MODEL #: SC-1110 |