FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 17208185
·
Received June 27, 2023
Report
- Report Number
- 3006630150-2023-03668
- Event Type
- Injury
- Date Received
- June 27, 2023
- Date of Event
- March 30, 2022
- Report Date
- June 27, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN M365NM3138550. MODEL NM-3138-55. SERIAL/LOT (B)(6). BATCH 7072991.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEALING ISSUE AND SKIN DEHISCENCE AT THE LEAD EXTENSION SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE TWO LEAD EXTENSIONS WERE EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. THE PATIENT WAS DOING FINE POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841659 | NA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | NM-3138-55 | 7072844 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |