MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-1110-C
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event unknown.Approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient was experiencing difficulties communicating between his deep brain stimulation (dbs) implantable pulse generator (ipg).Attempts to establish communication with the ipg and several remote controls and clinician programmers were made, however were unsuccessful.The patient underwent a procedure where the ipg was replaced with another of a different model.The patient did well post-operatively.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
The returned vercise ipg was analyzed and passed all functional testing and exhibited normal visual characteristics.The ipg was able to be fully charged in one cycle and successfully paired with a good known remote control (rc).A labeling review was conducted and did not reveal any anomalies.Additionally strong electromagnetic fields can potentially turn stimulator off or cause temporary changes in stimulation of interfere with the rc communication as stated in the instructions for use (ifu).Based on a review of all available information, the cause of the reported event could not be confirmed and engineers concluded that no problem was detected.
Event or Problem Description
It was reported that the patient was experiencing difficulties communicating between his deep brain stimulation (dbs) implantable pulse generator (ipg).Attempts to establish communication with the ipg and several remote controls and clinician programmers were made, however were unsuccessful.The patient underwent a procedure where the ipg was replaced with another of a different model.The patient did well post-operatively.No further information has been obtained despite good faith efforts.

• Brand Name: VERCISE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20263860
• Report Number: 3006630150-2024-06282
• Device Sequence Number: 18323642
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/16/2017
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 17763048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown