FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 17311933
·
Received July 12, 2023
Report
- Report Number
- 3006630150-2023-04069
- Event Type
- Injury
- Date Received
- July 12, 2023
- Date of Event
- April 18, 2023
- Report Date
- July 12, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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)(6); BATCH: 7093123.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233705 | NA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | NM-3138-55 | 7090210 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |