STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Report
- Report Number
- 3006630150-2021-04330
- Event Type
- Injury
- Date Received
- August 6, 2021
- Date of Event
- June 30, 2021
- Report Date
- October 18, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE RETURNED LEAD EXTENSIONS, SERIAL NUMBERS: (B)(6), PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS NO PROBLEM HAS BEEN DETECTED.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365DB321655C0; MODEL: DB-3216-55C; SERIAL: (B)(6); BATCH: 5000384. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365DB321655C0; MODEL: DB-3216-55C; SERIAL: (B)(6); BATCH: 5000382. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB220330C0; MODEL: DB-2203-30C; SERIAL: (B)(6); BATCH: 5000524.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE LEAD EXTENSIONS FOR THE CLINICAL STUDY PATIENT. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE LEAD EXTENSIONS FOR THE CLINICAL STUDY PATIENT. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED THAT ONE OF THE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS PREVIOUSLY MENTIONED, LEAD EXTENSION, MODEL NUMBER: DB-3216-55, SERIAL NUMBER: (B)(6) WAS NOT INVOLVED WITH THIS COMPLAINT AND THAT IT WAS LEAD, MODEL NUMBER: DB-2203-30C, SERIAL NUMBER: (B)(6) THAT WAS INVOLVED INSTEAD. THE LEAD WAS REVISED.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE LEAD EXTENSIONS FOR THE CLINICAL STUDY PATIENT. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED THAT ONE OF THE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS PREVIOUSLY MENTIONED, LEAD EXTENSION, MODEL NUMBER: DB-3216-55, SERIAL NUMBER: (B)(6) WAS NOT INVOLVED WITH THIS COMPLAINT AND THAT IT WAS LEAD, MODEL NUMBER: DB-2203-30C, SERIAL NUMBER: (B)(6) THAT WAS INVOLVED INSTEAD. THE LEAD WAS REVISED. ADDITIONAL INFORMATION WAS RECEIVED THAT ONE OF THE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS PREVIOUSLY MENTIONED, LEAD, MODEL NUMBER: DB-2203-30C, SERIAL NUMBER: (B)(6) WAS NOT INVOLVED WITH THIS COMPLAINT AND THAT IT WAS LEAD EXTENSION, MODEL NUMBER: DB-3216-55C, SERIAL NUMBER: (B)(6) THAT WAS INVOLVED INSTEAD, WHICH DID ALSO DISPLAY HIGH IMPEDANCES, HOWEVER NO ACTION WAS TAKEN.
THE SERIAL NUMBER FOR SUSPECT DEVICE IS (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB321655C0, MODEL: DB-3216-55C, SERIAL: (B)(4), BATCH: 5000384. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB321655C0, MODEL: DB-3216-55C, SERIAL: (B)(4), BATCH: 5000382. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(4), BATCH: 5000177.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE LEAD EXTENSIONS FOR THE CLINICAL STUDY PATIENT. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1184723 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-3216-55C | 5000369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |