FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2925913
·
Received January 22, 2013
Report
- Report Number
- 3006630150-2013-00122
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 7, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION CANNOT BE OBTAINED AT THIS TIME. SEVERAL ATTEMPTS WERE MADE TO FOLLOW-UP WITH THE PATIENT BUT WERE UNSUCCESSFUL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INTENSE PAIN AND DISCOMFORT WHETHER THE STIMULATION WAS ON OR OFF. THE PATIENT WENT TO EMERGENCY ROOM FOR PAIN TREATMENT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INTENSE PAIN AND DISCOMFORT WHETHER THE STIMULATION WAS ON OR OFF. THE PATIENT WENT TO EMERGENCY ROOM FOR PAIN TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29734 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |