FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2101363
·
Received May 24, 2011
Report
- Report Number
- 3006630150-2011-00740
- Event Type
- Injury
- Date Received
- May 24, 2011
- Date of Event
- April 12, 2011
- Report Date
- April 12, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS DONE.THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. CHARGE PROFILE REVEALED VARIOUS TIMES OF ERRATIC COUPLING/POOR ALIGNMENT OF THE CHARGER TO THE IPG. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Description of Event or Problem · 1
A PATIENT REPORTED CHARGING DIFFICULTIES AFTER SUFFERING A NON DEVICE RELATED FALL. THE PHYSICIAN REPLACED THE IMPLANTED PULSE GENERATOR ( IPG) DUE TO SUSPECTED DAMAGE. THE PATIENT IS REPORTEDLY DOING WELL AFTER REVISION SURGERY.
Description of Event or Problem · 1
A PATIENT REPORTED CHARGING DIFFICULTIES AFTER SUFFERING A NON DEVICE RELATED FALL. THE PHYSICIAN REPLACED THE IMPLANTED PULSE GENERATOR ( IPG) DUE TO SUSPECTED DAMAGE. THE PATIENT IS REPORTEDLY DOING WELL AFTER REVISION SURGERY.
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 | 63 YR | Required Intervention |