FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 7676140
·
Received July 10, 2018
Report
- Report Number
- 3006630150-2018-60097
- Event Type
- Injury
- Date Received
- July 10, 2018
- Date of Event
- May 25, 2018
- Report Date
- July 10, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 3072927/3073186, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT, 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE AND WAS GETTING SHOCKED LIKE SENSATION IN THE AREA OF SCS. IT WAS MENTIONED THAT THE PATIENT HAD LOST WEIGHT AND THE IPG WAS TILTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS MOVED UP IN THE LUMBAR AREA AND THE IPG WAS MOVED DOWN. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 516016 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 20326198 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |