VERCISE GENUS
Report
- Report Number
- 3006630150-2024-07025
- Event Type
- Injury
- Date Received
- October 16, 2024
- Date of Event
- September 17, 2024
- Report Date
- December 6, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL PRO CODE SELECTIONS THAT APPLY TO THE INDICATION OF THIS DEVICE - MHY, PJS.
ADDITIONAL PRO CODE SELECTIONS THAT APPLY TO THE INDICATION OF THIS DEVICE - MHY, PJS.
IT WAS REPORTED THAT DURING THE REVISION PROCEDURE TO REPLACE THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION DUE TO UNKNOWN REASON THE PHYSICIAN EXPERIENCED DIFFICULTY DISCONNECTING THE LEAD EXTENSION FROM THE DIRECTIONAL LEAD BUT WAS ABLE TO SUCCESSFULLY REPLACE THE LEAD EXTENSION. FOLLOWING THE PROCEDURE BOTH THE CLINICIAN PROGRAMMER (CP) AND THE PATIENT REMOTE CONTROL WERE UNABLE TO ESTABLISH A CONNECTION TO THE IMPLANTABLE PULSE GENERATOR (IPG). A PLASMA BLADE WAS USED TO PERFORM THE LEAD EXTENSION REPLACEMENT AND POSSIBLY COMPROMISED THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE MODEL, SERIAL NUMBER, AND EXPLANT DATE OF THE IPG.
IT WAS REPORTED THAT DURING THE REVISION PROCEDURE TO REPLACE THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION DUE TO UNKNOWN REASON THE PHYSICIAN EXPERIENCED DIFFICULTY DISCONNECTING THE LEAD EXTENSION FROM THE DIRECTIONAL LEAD BUT WAS ABLE TO SUCCESSFULLY REPLACE THE LEAD EXTENSION. FOLLOWING THE PROCEDURE BOTH THE CLINICIAN PROGRAMMER (CP) AND THE PATIENT REMOTE CONTROL WERE UNABLE TO ESTABLISH A CONNECTION TO THE IMPLANTABLE PULSE GENERATOR (IPG). A PLASMA BLADE WAS USED TO PERFORM THE LEAD EXTENSION REPLACEMENT AND POSSIBLY COMPROMISED THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE MODEL, SERIAL NUMBER, AND EXPLANT DATE OF THE IPG. THE EXPLANTED IPG WAS DISCARDED BY THE MEDICAL FACILITY AND WAS NOT RETURNED TO BSC. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
IT WAS REPORTED THAT DURING THE REVISION PROCEDURE TO REPLACE THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION DUE TO UNKNOWN REASON THE PHYSICIAN EXPERIENCED DIFFICULTY DISCONNECTING THE LEAD EXTENSION FROM THE DIRECTIONAL LEAD BUT WAS ABLE TO SUCCESSFULLY REPLACE THE LEAD EXTENSION. FOLLOWING THE PROCEDURE BOTH THE CLINICIAN PROGRAMMER (CP) AND THE PATIENT REMOTE CONTROL WERE UNABLE TO ESTABLISH A CONNECTION TO THE IMPLANTABLE PULSE GENERATOR (IPG). A PLASMA BLADE WAS USED TO PERFORM THE LEAD EXTENSION REPLACEMENT AND POSSIBLY COMPROMISED THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1034670 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 593180 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |