FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3982130
·
Received August 5, 2014
Report
- Report Number
- 3006630150-2014-01770
- Event Type
- Injury
- Date Received
- August 5, 2014
- Date of Event
- July 14, 2012
- Report Date
- July 14, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A REVISION PROCEDURE AT THIS TIME.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE PER PHYSICIAN'S PREFERENCE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE IPG WAS NOT HOLDING A CHARGE AND POCKET WAS SHALLOW. THE PATIENT WILL UNDERGO A POCKET REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE IPG WAS NOT HOLDING A CHARGE AND POCKET WAS SHALLOW. THE PATIENT WILL UNDERGO A POCKET REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE IPG WAS NOT HOLDING A CHARGE AND POCKET WAS SHALLOW. THE PATIENT WILL UNDERGO A POCKET REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456616 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |