FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 16045673
·
Received December 23, 2022
Report
- Report Number
- 3006630150-2022-07273
- Event Type
- Injury
- Date Received
- December 23, 2022
- Date of Event
- December 5, 2022
- Report Date
- December 23, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7101710.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD SCABS NEAR THE BURR HOLE COVER INCISION SITE THAT WILL NOT HEAL. THE PHYSICIAN CONFIRMED THAT THE INCISION IS NOT INFECTED. THE PATIENT WILL DO HYPERBARIC OXYGEN TREATMENTS TO PROMOTE HEALING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2138188 | NA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | NM-3138-55 | 7101052 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |