VERCISE GENUS
Report
- Report Number
- 3006630150-2023-05369
- Event Type
- Injury
- Date Received
- September 6, 2023
- Date of Event
- July 21, 2023
- Report Date
- November 17, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729985044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7091693. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7091358. CORRECTION TO FOLLOW-UP 1 MDR IN FIELD B5.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7091693. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 . MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7091358.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE, EXPOSURE OF THEIR IMPLANT, AND AN INFECTION AT THEIR IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE. THE PATIENT WAS ADMINISTERED ORAL STEROIDS AND A TOPICAL ANTISEPTIC AS WELL AS UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD EXTENSIONS HAD BEEN CUT AT THE IPG POCKET SITE AND PARTIALLY REMOVED DURING THE EXPLANT PROCEDURE. THE PATIENT THEN UNDERWENT AN ADDITIONAL PROCEDURE WHERE THE REMAINING PORTIONS OF THE LEAD EXTENSIONS WERE EXPLANTED. THERE WERE NO REPORTED COMPLICATIONS POST OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE, EXPOSURE OF THEIR IMPLANT, AND AN INFECTION AT THEIR IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE. THE PATIENT WAS ADMINISTERED ORAL STEROIDS AND A TOPICAL ANTISEPTIC AS WELL AS UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG WAS REMOVED. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE, EXPOSURE OF THEIR IMPLANT, AND AN INFECTION AT THEIR IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE. THE PATIENT WAS ADMINISTERED ORAL STEROIDS AND A TOPICAL ANTISEPTIC AS WELL AS UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG WAS REMOVED. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1122606 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1216 | 524033 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |