VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-03903
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- May 20, 2025
- Report Date
- October 7, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT, EXACT EVENT DATE UNKNOWN.
CORRECTION TO FIELD B3 DATE OF EVENT. THE RETURNED IPG DB-1216 SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE LEAD DB-2202-30 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE LEAD DB-2202-30 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE LEAD EXTENSION NM-3138-55 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE LEAD EXTENSION NM-3138-55 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE BURR HOLE COVER DB-4600-C LOT 33968932 WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE BURR HOLE COVER DB-4600-C LOT 33968932 WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. IT STATES THAT INFECTION AND FEVER ARE KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION (DBS).
CORRECTION TO FIELD H11 - LABELING. THE RETURNED IPG DB-1216 SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE LEAD DB-2202-30 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE LEAD DB-2202-30 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE LEAD EXTENSION NM-3138-55 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE LEAD EXTENSION NM-3138-55 SERIAL NUMBER (B)(6) WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE BURR HOLE COVER DB-4600-C LOT 33968932 WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. THE BURR HOLE COVER DB-4600-C LOT 33968932 WAS RETURNED TO BOSTON SCIENTIFIC. HOWEVER, PER SECTION 72 (6) OF THE MEDICAL DEVICE IMPLEMENTATION ACT (MPDG), PATIENT CONSENT IS REQUIRED BEFORE ANY PRODUCT ANALYSIS MAY OCCUR ON A PATIENT OWNED DEVICE. AT THIS TIME, PATIENT CONSENT FOR ANALYSIS OF THIS DEVICE HAS NOT BEEN RECEIVED. THEREFORE, THE DEVICE HAS BEEN ARCHIVED WITHOUT ANALYSIS. IF PATIENT CONSENT IS RECEIVED AT A LATER DATE, ANALYSIS WILL BE COMPLETED AT THAT TIME. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. IT STATES THAT INFECTION, FEVER, REDNESS, AND SWELLING ARE KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION (DBS).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7136041, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA, BATCH: 33968932, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA, BATCH: 33968932, UDI: (B)(4).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SUDDEN INCREASE IN C-REACTIVE PROTEIN (CRP) INDICATING A POSSIBLE INFECTION. CULTURES WERE TAKEN AND CONFIRMED A STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SUDDEN INCREASE IN C-REACTIVE PROTEIN (CRP) INDICATING A POSSIBLE INFECTION. CULTURES WERE TAKEN AND CONFIRMED A STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FULL DBS SYSTEM WAS EXPLANTED. IT WAS ALSO INDICATED THAT THE SYMPTOMS THE PATIENT EXPERIENCED DUE TO THE INFECTION WERE SIGNS OF REDNESS AND SWELLING AT THE SITE AND FEVER. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE CORRECT EVENT DATE WAS ALSO PROVIDED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SUDDEN INCREASE IN C-REACTIVE PROTEIN (CRP) INDICATING A POSSIBLE INFECTION. CULTURES WERE TAKEN AND CONFIRMED A STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FULL DBS SYSTEM WAS EXPLANTED. IT WAS ALSO INDICATED THAT THE SYMPTOMS THE PATIENT EXPERIENCED DUE TO THE INFECTION WERE SIGNS OF REDNESS AND SWELLING AT THE SITE AND FEVER. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE CORRECT EVENT DATE WAS ALSO PROVIDED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SUDDEN INCREASE IN C-REACTIVE PROTEIN (CRP) INDICATING A POSSIBLE INFECTION. CULTURES WERE TAKEN AND CONFIRMED A STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FULL DBS SYSTEM WAS EXPLANTED. IT WAS ALSO INDICATED THAT THE SYMPTOMS THE PATIENT EXPERIENCED DUE TO THE INFECTION WERE SIGNS OF REDNESS AND SWELLING AT THE SITE AND FEVER. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE CORRECT EVENT DATE WAS ALSO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 888530 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 778235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |