FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1760749
·
Received July 15, 2010
Report
- Report Number
- 3006630150-2010-01240
- Event Type
- Injury
- Date Received
- July 15, 2010
- Date of Event
- May 18, 2010
- Report Date
- May 20, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT WAS EXPERIENCING PAIN AT THE BATTERY SITE AND THAT THE STIMULATION WAS AGGRAVATING HER HERNIA IN HER GROIN. THE PT WAS REPROGRAMMED WHICH RESOLVED THE GROIN DISCOMFORT. THE PT'S MEDICATION WAS ALTERED TO ADDRESS THE PRE-EXISTING MEDICAL CONDITION. THE PT CONTINUED TO EXPERIENCE PAIN AT THE IPG SITE AND WAS PRESCRIBED TOPICAL CREAM. THE PT HAS NOW BEEN SCHEDULED TO HAVE THE ENTIRE SYSTEM EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | ARTISAN 2X8 PADDLE LEAD (LIM), 50 CM:| MODEL #: SC-8120-50,| SERIAL #: (B)(4) |