FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2970499
·
Received February 20, 2013
Report
- Report Number
- 3006630150-2013-00277
- Event Type
- Injury
- Date Received
- February 20, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 28, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2366-50. SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 50CM MODEL #: SC-4316. SERIAL/LOT #: (B)(4), DESCRIPTION: CLIK ANCHOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SENSITIVITY AND PAIN AT THE POCKET AND THE LEAD SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPORTEDLY DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75072 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention |