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

Model Number	DB-1140-S
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's implantable pulse generator (ipg) was depleted.The physician has requested an analysis to determine if the battery depletion was normal.
Additional Manufacturer Narrative
Correction to the initial mdr in block b5.Analysis on the returned ipg revealed that the ipg could be linked with a remote control but could not be linked with an interrogative software tool.Attempts to bring up the device from the end of service state using an external power source failed.The printed circuit board level electrical test revealed normal device characteristics.The ipg was no longer responding thus the longevity of the device could not be determined.The device was damaged during the explant procedure due to an unknown source; it could not be confirmed if electrocautery was used during the procedure.The complaint of ipg depletion after 22 months could not be investigated as the device was no longer functioning and the data log was not retrievable.The cause of the complaint could not be established.
Event or Problem Description
It was reported that the patient's primary cell implantable pulse generator (ipg) had reached the end of life battery message.The patient underwent a routine battery replacement procedure and was doing fine post-operatively.The physician requested an analysis to determine if the battery depletion was normal.

• Brand Name: VERCISE PC
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13252744
• Report Number: 3006630150-2022-00045
• Device Sequence Number: 19981835
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 12/13/2020
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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 Age: 76 YR
• Patient Sex: Male