FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2080758
·
Received May 6, 2011
Report
- Report Number
- 3006630150-2011-00683
- Event Type
- Injury
- Date Received
- May 6, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A POCKET REVISION DUE TO DISCOMFORT. DURING THE PROCEDURE, THE PHYSICIAN NOTICED DISCOLORATION IN ONE OF THE IPG PORTS. THE PHYSICIAN BELIEVED IT COULD HAVE BEEN BLOOD, TISSUE OR THAT THE LEAD WAS NOT PROPERLY WIPED DOWN PRIOR TO INSERTING IT INTO THE PORT. THE PHYSICIAN REPOSITIONED THE PATIENT'S POCKET SITE. ALL CONNECTIONS WERE GOOD AND NOTHING WAS IMPLANTED OR EXPLANTED. THE PATIENT 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 | Required Intervention |