VERCISE GENUS
Report
- Report Number
- 3006630150-2022-01627
- Event Type
- Injury
- Date Received
- April 13, 2022
- Date of Event
- March 22, 2022
- Report Date
- March 15, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7086690. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7086717.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, BATCH/ SERIAL: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, BATCH/ SERIAL: (B)(6). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, BATCH/ SERIAL: (B)(6). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, BATCH/ SERIAL: (B)(6).
DEVICE ANALYSIS PERFORMED ON THE RETURNED IPG, DB-1216 SERIAL (B)(6) PASSED INSPECTION AND REVEALED NO ANOMALIES. ADDITIONALLY, VISUAL INSPECTION PERFORMED ON THE RETURNED LEAD DB-2202-45 SERIAL (B)(6), REVEALED THAT IT WAS CLEANLY CUT WITH ONLY THE PROXIMAL END OF THE LEAD BEING RETURNED. THE LEAD EXTENSIONS, NM-3138-55 SERIAL (B)(6), WERE ALSO RETURNED WITH A VISUAL INSPECTION THAT REVEALED A CLEAN CUT AT THE LEAD EXTENSION CONNECTOR PORTION. THIS DAMAGE TO THE LEAD AND LEAD EXTENSIONS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND THEREFORE, NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTIONS OF THE LEAD AND LEAD EXTENSIONS. A PRODUCT LABELING REVIEW THAT WAS CONDUCTED DETERMINED THAT INFECTION IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF THE DBS DEVICE, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7086690. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7086717. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7091109. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7093358.
IT WAS REPORTED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM DUE TO A POTENTIAL INFECTION. NO FURTHER INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS.
IT WAS REPORTED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM DUE TO A POTENTIAL INFECTION. NO FURTHER INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS.
IT WAS REPORTED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM DUE TO A POTENTIAL INFECTION. NO FURTHER INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708993 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1216 | 520108 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |