VERCISE GENUS
Report
- Report Number
- 3006630150-2023-01009
- Event Type
- Injury
- Date Received
- March 3, 2023
- Date of Event
- February 6, 2023
- Report Date
- June 5, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL:(B)(6). BATCH: 7075212. PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: 7071499. THE RETURNED DBS ADAPTERS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(4), BATCH: 7075212. PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(4), BATCH: 7071499.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: (B)(6). THE RETURNED DBS ADAPTERS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. ANALYSIS OF THE RETURNED, DB-1216, SERIAL (B)(6), REVEALED THE IPG PASSED VISUAL INSPECTION AND WAS ABLE TO BE FULLY RECHARGED IN ONE FOUR-HOUR CHARGE CYCLE. IT WAS ABLE TO LINK TO A KNOWN GOOD REMOTE CONTROL AND IMPEDANCE MEASUREMENTS WERE ALL WITHIN NORMAL RANGE. HOWEVER, THE BATTERY QUICKLY DEPLETED AND WAS UNABLE TO HOLD A CHARGE. THE IPG WAS CUT OPEN AND THE BATTERY EXHIBITED A HIGH SLEEP CURRENT. ELECTRICAL TESTING REVEALED A LOW VH RESISTANCE MEASUREMENT, WHICH INDICATES AN ELECTRICAL SHORT WITHIN THE APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC). THE DAMAGED ASIC RESULTED IN THE PREMATURE BATTERY DEPLETION POST IMPLANT. THIS TYPE OF DAMAGE IS TYPICALLY CAUSED WHEN THE IPG IS EXPOSED TO HIGH VOLTAGE TRANSIENTS. EXPOSURE TO ELECTROCAUTERY CAN CAUSE THIS TYPE OF DAMAGE. THE IPG WAS LIKELY DAMAGED DURING THE IMPLANT PROCEDURE DUE TO BEING EXPOSED TO HIGH VOLTAGE TRANSIENTS THUS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS HAVING DIFFICULTY COMMUNICATING WITH AND CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND HIGH IMPEDANCES. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING FINE POST-OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS HAVING DIFFICULTY COMMUNICATING WITH AND CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND HIGH IMPEDANCES. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING FINE POST-OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS HAVING DIFFICULTY COMMUNICATING WITH AND CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND HIGH IMPEDANCES. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING FINE POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1913898 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1216 | 558382 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |