FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1852444
·
Received September 29, 2010
Report
- Report Number
- 3006630150-2010-01603
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- August 31, 2010
- Report Date
- August 31, 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
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. THE PHYSICIAN OBSERVED PUS AT THE POCKET SITE AND TREATED BY PLACING A POUCH OVER THE SITE TO DRAIN THE POCKET AND TO ADMINISTER ANTIBIOTICS. THE PHYSICIAN DID NOT INDICATE WHETHER THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS PLACED ON BOTH ORAL AND IV ANTIBIOTICS AND IS REPORTEDLY DOING FINE.
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 | UNK | Required Intervention | ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.012" STYLET| SERIAL #: (B)(4)| MODEL # : SC-2208-50| SERIAL #: (B)(4) |