VERCISE GENUS
Report
- Report Number
- 3006630150-2024-09027
- Event Type
- Injury
- Date Received
- December 26, 2024
- Date of Event
- September 28, 2024
- Report Date
- December 26, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7072239. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7082277. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7116515. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7115376. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7115079.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED REDNESS AND SWELLING OVER THEIR IMPLANTABLE PULSE GENERATOR (IPG) POCKET IN THEIR CHEST. THE PHYSICIAN ASSESSED THAT THE PATIENT HAD DEVELOPED AN INFECTION. IT WAS UNKNOWN IF A CULTURE WAS TAKEN. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE, WAS ADMITTED TO THE HOSPITAL, AND WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE FACILITY AND NOT RETURNED TO BE ANALYZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2281365 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 593504 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Required Intervention |