STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Report
- Report Number
- 3006630150-2024-00492
- Event Type
- Injury
- Date Received
- February 5, 2024
- Date of Event
- January 11, 2024
- Report Date
- September 30, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729836544
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312895B0, MODEL: DB-3128-95B, SERIAL: (B)(6), BATCH: 5000181.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312895B0, MODEL: DB-3128-95B, SERIAL: (B)(6), BATCH: 5000181.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB312895B0. MODEL: DB-3128-95B. SERIAL: (B)(6). BATCH: 5000181. ANALYSIS OF RETURNED LEAD EXTENSION, DB-3128-95B (5000181), CONSISTED OF A VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD EXTENSION WHICH REVEALED THAT THREE CABLES ARE COMPLETELY BROKEN AT THE BENT KINKED SECTION CLOSE TO THE PROXIMAL END, NEAR THE VENT PORT. NO CABLES ARE EXPOSED AT THIS PORTION OF THE LEAD EXTENSION. THE LEAD EXTENSION ANOMALY RESULTED IN THE REPORTED COMPLAINT. HOWEVER, ALTHOUGH THE POTENTIAL CAUSE OF THE OBSERVED IMPEDANCE HAS BEEN IDENTIFIED, THE NATURE OF HOW THE PROXIMAL TAIL BODY OR THE CABLES WITHIN THE BODY FRACTURED IS UNKNOWN. FURTHER INVESTIGATION IS REQUIRED TO ASSESS THE ROOT CAUSE, THUS CAUSE NOT ESTABLISHED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE DYSTONIA COVERAGE. IMPEDANCES WERE OBSERVED AND TWO SURGERIES WERE PERFORMED TO IDENTIFY THE SOURCE OF THE IMPEDANCES. THE PHYSICIAN INITIALLY REPLACED THE LEAD BUT THE IMPEDANCES REMAINED, SO A SECOND REVISION WAS PERFORMED TO REPLACE THE LEAD EXTENSION. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE DYSTONIA COVERAGE. IMPEDANCES WERE OBSERVED AND TWO SURGERIES WERE PERFORMED TO IDENTIFY THE SOURCE OF THE IMPEDANCES. THE PHYSICIAN INITIALLY REPLACED THE LEAD BUT THE IMPEDANCES REMAINED, SO A SECOND REVISION WAS PERFORMED TO REPLACE THE LEAD EXTENSION. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE EXPLANTED LEAD WAS DISCARDED BY THE FACILITY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE DYSTONIA COVERAGE. IMPEDANCES WERE OBSERVED AND TWO SURGERIES WERE PERFORMED TO IDENTIFY THE SOURCE OF THE IMPEDANCES. THE PHYSICIAN INITIALLY REPLACED THE LEAD BUT THE IMPEDANCES REMAINED, SO A SECOND REVISION WAS PERFORMED TO REPLACE THE LEAD EXTENSION. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE EXPLANTED LEAD WAS DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2091259 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | DB-2201-45-DC | 21387922 | 08714729836544 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male | Required Intervention |