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

Model Number	DB-9218-15
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that high impedances were noted on the m8 lead adaptor.The patient underwent a revision procedure in which the m8 lead adaptor was replaced.The procedure was completed and the impedance values were within the normal range.
Additional Manufacturer Narrative
The complaint of high impedances was confirmed through product analysis.The probable cause was traced to unintended use error caused or contributed to event.
Event or Problem Description
It was reported that high impedances were noted on the m8 lead adaptor.The patient underwent a revision procedure in which the m8 lead adaptor was replaced.The procedure was completed and the impedance values were within the normal range.
Event or Problem Description
It was reported that high impedances were noted on the m8 lead adaptor.The patient underwent a revision procedure in which the m8 lead adaptor was replaced.The procedure was completed and the impedance values were within the normal range.
Additional Manufacturer Narrative
The device was not returned for analysis and the complaint of high impedances could not be confirmed.Record review revealed no additional information related to the complaint.The investigation is unable to determine a probable cause for the complaint; therefore, the cause cannot be established.

• Brand Name: VERCISE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10159785
• Report Number: 3006630150-2020-02482
• Device Sequence Number: 19766036
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2020

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: 02/02/2019
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 20232527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/22/2020; 10/23/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 06/26/2020; 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention