VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-05633
- Event Type
- Injury
- Date Received
- July 18, 2025
- Date of Event
- May 23, 2025
- Report Date
- April 8, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE RETURNED IPG WAS RECEIVED WITH A PART OF THE LEAD EXTENSION CAUGHT AT PORT. THE PORTION OF THE LEAD EXTENSION WAS SUCCESSFULLY REMOVED AND THE IPG EXHIBITED TYPICAL CHARACTERISTICS DURING BOTH VISUAL AND FUNCTIONAL ASSESSMENTS. THE EVENT OF INADEQUATE STIMULATION IS A KNOWN INHERENT RISK WITH IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION. BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED A MONTH PRIOR TO REPLACEMENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5003248, UDI: (B)(4).
CORRECTION TO THE FOLLOW-UP 3 MDR IN BLOCK B5 AND H6. CORRECTION TO THE FOLLOW-UP 2 MDR IN BLOCK H6. THE RETURNED LEAD EXTENSION RECEIVED EXHIBITED A PROXIMAL TAIL BREAKAGE OF THE CABLE AND THE LEAD EXTENSION BODY. THE REPORTED EVENT WAS CONFIRMED; IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE LEAD EXTENSION, RESULTING IN THE DAMAGE. THEREFORE, THE PROBABLE CAUSE OF THIS INVESTIGATION IS A CAUSE TRACED TO COMPONENT FAILURE. THE RETURNED IPG WAS RECEIVED WITH A PART OF THE LEAD EXTENSION CAUGHT AT PORT. THE PORTION OF THE LEAD EXTENSION WAS SUCCESSFULLY REMOVED AND THE IPG EXHIBITED TYPICAL CHARACTERISTICS DURING BOTH VISUAL AND FUNCTIONAL ASSESSMENTS. THE EVENT OF INADEQUATE STIMULATION IS A KNOWN INHERENT RISK WITH IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION. BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED A MONTH PRIOR TO REPLACEMENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB312855B0. MODEL: DB-3128-55B. SERIAL: (B)(6). BATCH: 5003248. UDI: (B)(4).
CORRECTION TO THE FOLLOW-UP 2 MDR IN BLOCK H6. THE RETURNED LEAD EXTENSION RECEIVED EXHIBITED A PROXIMAL TAIL BREAKAGE OF THE CABLE AND THE LEAD EXTENSION BODY. THE REPORTED EVENT WAS CONFIRMED; IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE LEAD EXTENSION, RESULTING IN THE DAMAGE. THEREFORE, THE PROBABLE CAUSE OF THIS INVESTIGATION IS A CAUSE TRACED TO COMPONENT FAILURE. THE RETURNED IPG WAS RECEIVED WITH A PART OF THE LEAD EXTENSION CAUGHT AT PORT. THE PORTION OF THE LEAD EXTENSION WAS SUCCESSFULLY REMOVED AND THE IPG EXHIBITED TYPICAL CHARACTERISTICS DURING BOTH VISUAL AND FUNCTIONAL ASSESSMENTS. THE EVENT OF INADEQUATE STIMULATION IS A KNOWN INHERENT RISK WITH IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION. BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED A MONTH PRIOR TO REPLACEMENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365DB312855B0; MODEL: DB-3128-55B; SERIAL: (B)(6); BATCH: 5003248; UDI: (B)(4).
BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED A MONTH PRIOR TO REPLACEMENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB312855B0. MODEL: DB-3128-55B. SERIAL: (B)(6). BATCH: 5003248. UDI: (B)(4).
THE RETURNED LEAD EXTENSION RECEIVED EXHIBITED A PROXIMAL TAIL BREAKAGE OF THE CABLE AND THE LEAD EXTENSION BODY. THE REPORTED EVENT WAS CONFIRMED; IT APPEARS THAT EXCESSIVE MECHANICAL FORCE WAS EXERTED ONTO THE LEAD EXTENSION, RESULTING IN THE DAMAGE. THEREFORE, THE PROBABLE CAUSE OF THIS INVESTIGATION IS A CAUSE TRACED TO COMPONENT FAILURE. THE RETURNED IPG WAS RECEIVED WITH A PART OF THE LEAD EXTENSION CAUGHT AT PORT. THE PORTION OF THE LEAD EXTENSION WAS SUCCESSFULLY REMOVED AND THE IPG EXHIBITED TYPICAL CHARACTERISTICS DURING BOTH VISUAL AND FUNCTIONAL ASSESSMENTS. THE EVENT OF INADEQUATE STIMULATION IS A KNOWN INHERENT RISK WITH IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION. BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED A MONTH PRIOR TO REPLACEMENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB312855B0. MODEL: DB-3128-55B. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEAD EXTENSION AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. DURING THE PROCEDURE, THE LEAD EXTENSION SHOWED SIGNS OF COMPROMISED INSULATION AND PARTIAL DAMAGE AT THE IPG HEADER, WHICH LED TO THE DECISION TO EXPLANT AND REPLACE BOTH THE LEAD EXTENSION AND THE IPG. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION AND IMPEDANCE ISSUES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEAD EXTENSION SHOWED SIGNS OF COMPROMISED INSULATION AND PARTIAL DAMAGE AT THE IPG HEADER, DUE TO WHICH THE EXTENSION TAILS WERE NOT ABLE TO BE REMOVED FROM IPG HEADER. AS A RESULT, THE LEAD EXTENSION AND THE IPG WERE EXPLANTED AND REPLACED. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEAD EXTENSION AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. DURING THE PROCEDURE, THE LEAD EXTENSION SHOWED SIGNS OF COMPROMISED INSULATION AND PARTIAL DAMAGE AT THE IPG HEADER, WHICH LED TO THE DECISION TO EXPLANT AND REPLACE BOTH THE LEAD EXTENSION AND THE IPG. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEAD EXTENSION AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. DURING THE PROCEDURE, THE LEAD EXTENSION SHOWED SIGNS OF COMPROMISED INSULATION AND PARTIAL DAMAGE AT THE IPG HEADER, WHICH LED TO THE DECISION TO EXPLANT AND REPLACE BOTH THE LEAD EXTENSION AND THE IPG. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEAD EXTENSION AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. DURING THE PROCEDURE, THE LEAD EXTENSION SHOWED SIGNS OF COMPROMISED INSULATION AND PARTIAL DAMAGE AT THE IPG HEADER, WHICH LED TO THE DECISION TO EXPLANT AND REPLACE BOTH THE LEAD EXTENSION AND THE IPG. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400335 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 752009 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |