VERCISE GENUS
Report
- Report Number
- 3006630150-2023-05194
- Event Type
- Injury
- Date Received
- August 30, 2023
- Date of Event
- January 17, 2023
- Report Date
- October 11, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ANALYSIS OF THE RETURNED LEAD EXTENSION DB-3128-55 ((B)(6)) REVEALED THAT AN X-RAY INSPECTION SHOWED CONTACTS 5 AND 8 OF THE PROXIMAL END OF THE LEAD EXTENSION HAD FRACTURED CABLES AT THE RIGHT WELD NUGGET. THE STRANDED CABLES APPEARED TO HAVE BEEN DAMAGED DURING THE MANUFACTURING PROCESS, POTENTIALLY AT THE WELDING OPERATION, RESULTING IN A WEAK WELD CONNECTION. THEREFORE, THE CAUSE OF THE EVENT IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY.
ANALYSIS OF THE RETURNED LEAD EXTENSION DB-3128-55 (5000197) REVEALED THAT AN X-RAY INSPECTION FOUND THAT MULTIPLE CABLES WERE FRACTURED CLOSE TO THE RETENTION SLEEVE. THE FRACTURED CABLES RESULTED IN THE REPORTED HIGH IMPEDANCES. THE FRACTURES ARE LIKELY DUE TO MECHANICAL STRESS FROM POSSIBLE FLEXING OF THE LEAD EXTENSION BODY. THEREFORE, THE CAUSE IS TRACED TO COMPONENT FAILURE.
ANALYSIS OF THE RETURNED LEAD EXTENSION DB-3128-55 (5000197) REVEALED THAT AN X-RAY INSPECTION FOUND THAT MULTIPLE CABLES WERE FRACTURED CLOSE TO THE RETENTION SLEEVE. THE FRACTURED CABLES RESULTED IN THE REPORTED HIGH IMPEDANCES. ALTHOUGH THE POTENTIAL CAUSE OF THE OBSERVED HIGH IMPEDANCE HAS BEEN IDENTIFIED, THE NATURE OF HOW THE PROXIMAL TAIL BODY OR THE CABLES WITHIN THE BODY FRACTURED, IS UNKNOWN. FURTHER INVESTIGATION IS REQUIRED TO ASSESS THE ROOT CAUSE. THE PROBABLE CAUSE IS CAUSE NOT ESTABLISHED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEAD EXTENSION. THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEAD EXTENSION. THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEAD EXTENSION. THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEAD EXTENSION. THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1184043 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-3128-55 | 5000197 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |