VERCISE CARTESIA
Report
- Report Number
- 3006630150-2024-05078
- Event Type
- Malfunction
- Date Received
- August 3, 2024
- Date of Event
- December 13, 2023
- Report Date
- March 10, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729905288
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL:(B)(6), BATCH: 7096091 . PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7102706. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7104241. PRODUCT FAMILY: DBS-IPG-PC UPN: M365DB14160, MODEL: DB-1416, SERIAL: (B)(6), BATCH: 207472.
THE LEAD DEVICES REMAIN IMPLANTED; THEREFORE, A TECHNICAL PRODUCT ANALYSIS CANNOT BE COMPLETED. HOWEVER, ANALYSIS OF THE RETURNED VERCISE GENUS IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSIONS PASSED ALL VISUAL AND FUNCTIONAL TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. ADDITIONALLY, A LABELING REVIEW IDENTIFIED FIBROSIS (THICKENED SKIN AND SCARRING) AROUND THE LEAD EXTENSION (INCLUDING TIGHTENING, TETHERING, AND BOWSTRINGING)" AND "FAILURE OR MALFUNCTION OF ANY PART OF THE DEVICE, INCLUDING BUT NOT LIMITED TO: BATTERY LEAKAGE, BATTERY FAILURE, LEAD OR EXTENSION BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS, AND LEAD INSULATION BREACHES, WHETHER OR NOT THESE PROBLEMS REQUIRE DEVICE REMOVAL AND/OR REPLACEMENT" ARE A KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION. WITH ALL THE AVAILABLE INFORMATION ENGINEERS CONCLUDED THE PATIENT EXPERIENCING TIGHTNESS AROUND THE DBS LEAD EXTENSION NECK SITE AND SCAR TISSUE FORMED AT THE LEAD EXTENSION ARE KNOWN RISKS WITH THE USE OF THE DEVICE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DB.S-IPG-PC. UPN: M365DB14160. MODEL: DB-1416. SERIAL: (B)(6). BATCH: 207472. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7102706. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7104241.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-IPG-PC, UPN: M365DB14160, MODEL: DB-1416, SERIAL: (B)(6), BATCH: (B)(6).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TIGHTNESS AROUND THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSIONS NECK SITE. THE PATIENT UNDERWENT A PROCEDURE WHERE SCAR TISSUE WAS REMOVED FROM THE LEAD EXTENSIONS, IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITE IN ADDITION TO HAVING A NON-DBS NECK FUSION PROCEDURE DURING THE REVISION. A HIGH IMPEDANCE WAS DISCOVERED FOLLOWING THE PROCEDURE WHERE THE LEAD EXTENSION WAS POSSIBLY DAMAGED BY THE NECK FUSION PROCEDURE PER THE PHYSICIAN'S ASSESSMENT. A REVISION TO ADDRESS THE HIGH IMPEDANCES HAS NOT BEEN SCHEDULED HOWEVER IT WAS NOTED THAT DBS DEVICES REMAIN IMPLANTED AND THERE WERE NO STIMULATION CHANGES DUE TO THE HIGH IMPEDANCE AND IS DELIVERING THERAPY. PATIENT DID WELL POST-OPERATIVELY. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN TESTING FOR THE HIGH IMPEDANCE WAS PERFORMED AND DETERMINED REPLACING THE DBS LEAD EXTENSIONS ON (B)(6) 2024 IN ADDITION TO THE DBS NON-RECHARGEABLE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED WITH A RECHARGEABLE IPG HOWEVER THE HIGH IMPEDANCE WAS STILL PRESENT. IT WAS NOTED THAT THE DBS LEADS REMAIN IMPLANTED, AND NO STIMULATION CHANGES DUE TO HIGH IMPEDANCE PER THE PHYSICIAN'S ASSESSMENT. PHYSICAL ANALYSIS OF THE DBS LEAD EXTENSIONS AND IPG WERE NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TIGHTNESS AROUND THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSIONS NECK SITE. THE PATIENT UNDERWENT A PROCEDURE WHERE SCAR TISSUE WAS REMOVED FROM THE LEAD EXTENSIONS, IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITE IN ADDITION TO HAVING A NON-DBS NECK FUSION PROCEDURE DURING THE REVISION. A HIGH IMPEDANCE WAS DISCOVERED FOLLOWING THE PROCEDURE WHERE THE LEAD EXTENSION WAS POSSIBLY DAMAGED BY THE NECK FUSION PROCEDURE PER THE PHYSICIANS ASSESSMENT. A REVISION TO ADDRESS THE HIGH IMPEDANCES HAS NOT BEEN SCHEDULED HOWEVER IT WAS NOTED THAT DBS DEVICES REMAIN IMPLANTED AND THERE WERE NO STIMULATION CHANGES DUE TO THE HIGH IMPEDANCE AND IS DELIVERING THERAPY. PATIENT DID WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TIGHTNESS AROUND THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSIONS NECK SITE. THE PATIENT UNDERWENT A PROCEDURE WHERE SCAR TISSUE WAS REMOVED FROM THE LEAD EXTENSIONS, IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITE IN ADDITION TO HAVING A NON-DBS NECK FUSION PROCEDURE DURING THE REVISION. A HIGH IMPEDANCE WAS DISCOVERED FOLLOWING THE PROCEDURE WHERE THE LEAD EXTENSION WAS POSSIBLY DAMAGED BY THE NECK FUSION PROCEDURE PER THE PHYSICIANS ASSESSMENT. A REVISION TO ADDRESS THE HIGH IMPEDANCES HAS NOT BEEN SCHEDULED HOWEVER IT WAS NOTED THAT DBS DEVICES REMAIN IMPLANTED AND THERE WERE NO STIMULATION CHANGES DUE TO THE HIGH IMPEDANCE AND IS DELIVERING THERAPY. PATIENT DID WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951635 | VERCISE CARTESIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-45 | 7096024 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention |