FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 10484361
·
Received September 2, 2020
Report
- Report Number
- 3006630150-2020-03870
- Event Type
- Injury
- Date Received
- September 2, 2020
- Date of Event
- August 10, 2020
- Report Date
- September 2, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: PRECISION SPECTRA IPG KIT, UPN: (B)(4), MODEL: SC-1132, SERIAL: (B)(4), BATCH: 204795. PRODUCT FAMILY: INFINION CX LEAD KIT, 70CM, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5150226 / 5151678.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ANY PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 946392 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 205016 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |