VERCISE GENUS?
Report
- Report Number
- 3006630150-2026-00168
- Event Type
- Injury
- Date Received
- January 7, 2026
- Date of Event
- March 1, 2025
- Report Date
- March 26, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE DB-1216, SERIAL NUMBER: (B)(6), WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT INFECTION, IMPLANTED DEVICE COMPONENTS (STIMULATOR, LEAD, OR LEAD EXTENSION) MAY MOVE FROM ORIGINAL IMPLANTED LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY AND IMPLANT SITE COMPLICATIONS SUCH AS PAIN, POOR HEALING, REDNESS, WARMTH, SWELLING OR WOUND REOPENING ARE A KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION (DBS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. THE DEVICE DB-3128-55B, SERIAL NUMBER: (B)(6), WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT INFECTION, IMPLANTED DEVICE COMPONENTS (STIMULATOR, LEAD, OR LEAD EXTENSION) MAY MOVE FROM ORIGINAL IMPLANTED LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY AND IMPLANT SITE COMPLICATIONS SUCH AS PAIN, POOR HEALING, REDNESS, WARMTH, SWELLING OR WOUND REOPENING ARE A KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION (DBS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - < 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: 5000416, UDI: (B)(4).
B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - 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: 5000416. UDI: (B)(4).
B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - < 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: 5000416. UDI: (B)(4).
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION WERE EXPLANTED DUE TO AN INFECTION. THE DEVICES WERE RETAINED DUE TO FACILITY POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE INFECTION WAS LOCATED AT THE CHEST POCKET PARIETAL INCISION, WHERE THE EXTENSION HAD BEEN PLACED. ACCORDING TO THE PHYSICIAN ASSESSMENT, THE INFECTION WAS NOT CONSIDERED DEVICE RELATED, AND NO PROCEDURAL FACTORS WERE BELIEVED TO HAVE CONTRIBUTED. THE CAUSE OF THE INFECTION REMAINED UNDETERMINED. THE PATIENT WAS PLACED ON ANTIBIOTIC THERAPY, AND CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT AVAILABLE. THE SYMPTOMS OF THE INFECTION WERE REDNESS, SWELLING, DISCHARGE AND WOUND DEHISCENCE.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION WERE EXPLANTED DUE TO AN INFECTION. THE DEVICES WERE RETAINED DUE TO FACILITY POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS FULLY RECOVERED.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION WERE EXPLANTED DUE TO AN INFECTION. THE DEVICES WERE RETAINED DUE TO FACILITY POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE INFECTION WAS LOCATED AT THE CHEST POCKET PARIETAL INCISION, WHERE THE EXTENSION HAD BEEN PLACED. ACCORDING TO THE PHYSICIAN ASSESSMENT, THE INFECTION WAS NOT CONSIDERED DEVICE RELATED, AND NO PROCEDURAL FACTORS WERE BELIEVED TO HAVE CONTRIBUTED. THE CAUSE OF THE INFECTION REMAINED UNDETERMINED. THE PATIENT WAS PLACED ON ANTIBIOTIC THERAPY, AND CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT AVAILABLE. THE SYMPTOMS OF THE INFECTION WERE REDNESS, SWELLING, DISCHARGE AND WOUND DEHISCENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60871 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 591698 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention |