FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2110713
·
Received June 1, 2011
Report
- Report Number
- 3006630150-2011-00801
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 13, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SERIAL NUMBER AND EXPIRATION DATE ARE UNKNOWN.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S IPG WAS REVISED AND THE PATIENT WAS REPORTEDLY DOING FINE. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE 1PG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A POCKET REVISION AS THE PATIENT HAD LOST WEIGHT, NON-DEVICE RELATED, AND THE IPG WAS PROTRUDING IN THE POCKET.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A POCKET REVISION AS THE PATIENT HAD LOST WEIGHT, NON-DEVICE RELATED, AND THE IPG WAS PROTRUDING IN THE POCKET.
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 | Required Intervention |