VERCISE GENUS¿
Report
- Report Number
- 3006630150-2022-00056
- Event Type
- Injury
- Date Received
- January 14, 2022
- Date of Event
- January 4, 2022
- Report Date
- October 18, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729985044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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-LOT (B)(6). BATCH 7081104 AND 7087826. PRODUCT FAMILY DBS-EXTENSION. UPN M365NM3138550. MODEL NM-3138-55. SERIAL-LOT (B)(6). BATCH 7091731 AND 7091740.
CORRECTION TO EMDR FOLLOW UP 2 IN BLOCK B5. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY DBS-LINEAR LEADS, UPN M365DB2202450, MODEL DB-2202-45, SERIAL-LOT (B)(6), BATCH 7081104 AND 7087826. PRODUCT FAMILY DBS-EXTENSION, UPN M365NM3138550, MODEL NM-3138-55, SERIAL-LOT (B)(6), BATCH 7091731 AND 7091740.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION AND UNDERWENT AN EXPLANT PROCEDURE.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION AND UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMINISTERED ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE REMAINING DEVICES WOULD BE EXPLANTED, HOWEVER THIS COULD NOT BE CONFIRMED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IPG EXPLANT PROCEDURE, THE LEAD EXTENSIONS WERE ALSO EXPLANTED, AND THE PROCEDURE OCCURRED ON (B)(6) 2023 NOT (B)(6) 2022. ADDITIONAL INFORMATION WAS ALSO RECEIVED THAT THE PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2022 IN WHICH THE REMAINING LEADS WERE EXPLANTED FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THERE WAS NO BOSTON SCIENTIFIC REPRESENTATIVE PRESENT DURING THE PROCEDURES. NO FURTHER INFORMATION CAN BE OBTAINED DESPITE GOOD FAITH EFFORTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION AND UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMINISTERED ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE REMAINING DEVICES WOULD BE EXPLANTED, HOWEVER THIS COULD NOT BE CONFIRMED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IPG EXPLANT PROCEDURE, THE LEAD EXTENSIONS WERE ALSO EXPLANTED, AND THE PROCEDURE OCCURRED ON (B)(6) 2022. ADDITIONAL INFORMATION WAS ALSO RECEIVED THAT THE PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2022 IN WHICH THE REMAINING LEADS WERE EXPLANTED FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THERE WAS NO BOSTON SCIENTIFIC REPRESENTATIVE PRESENT DURING THE PROCEDURES. NO FURTHER INFORMATION CAN BE OBTAINED DESPITE GOOD FAITH EFFORTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION AND UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMINISTERED ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE REMAINING DEVICES WOULD BE EXPLANTED, HOWEVER THIS COULD NOT BE CONFIRMED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807779 | VERCISE GENUS¿ | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1216 | 523404 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Hospitalization| R |