FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3933161
·
Received July 14, 2014
Report
- Report Number
- 3006630150-2014-01608
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS INADEQUATE PAIN RELIEF.
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DISCOMFORT AT THE BATTERY LOCATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DEVICE MALFUNCTION WAS NOT SUSPECTED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DISCOMFORT AT THE BATTERY LOCATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DEVICE MALFUNCTION WAS NOT SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409500 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |