FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 10870950
·
Received November 19, 2020
Report
- Report Number
- 3006630150-2020-05696
- Event Type
- Injury
- Date Received
- November 19, 2020
- Date of Event
- October 9, 2020
- Report Date
- November 19, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 19116806. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4316, SERIAL: NULL, BATCH: 19050906. PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: (B)(4) , MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 16321733. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4316, SERIAL: NULL, BATCH: 17146841.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1336358 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 203768 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |