MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE DEEP BRAIN STIMULATION SYSTEM; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1110-C

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2020

Event Type  malfunction  

Event Description

Unexpected failure; boston scientific vercise deep brain stimulation system rechargeable stimulator battery (implanted (b)(6) 2014; ipg model # db-1110-c; serial # (b)(4)) unexpectedly shut off on (b)(6) 2020 and on (b)(6) 2020.Error code appeared on remote control unit requiring patient to call the manufacturer for instructions on how to over-ride the error code in order to turn the battery (stimulator) back on.Manufacturer's representative suggested the patient might have been exposed to refrigerator magnets or other household magnets though this was not the case.Ten days later, the battery again shut off without warning.Battery will not restart unless patient manually restarts it using the system remote control unit.Since the cause of the shutoff has not been established, battery could shut off again without warning.Fda safety report id# (b)(4).

• Brand Name: VERCISE DEEP BRAIN STIMULATION SYSTEM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• MDR Report Key: 10725989
• MDR Text Key: 213002861
• Report Number: MW5097412
• Device Sequence Number: 1
• Product Code: NHL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1110-C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 64