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

Model Number	DB-9218-15
Medical Device Problem Codes	Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Code Available (3191)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the ipg was showing two high impedances on two therapeutic contacts, and it was causing inadequate stimulation for the patient.The stimulation was turned off as the physician opened patient up at the head site to test the lead, and pocket site to test the extension and adaptors.Physician assessed one of the adapters was broken.He replaced the broken adaptor with a new one.The patient was doing good post operatively and receiving good stimulation coverage.The device is pending return.
Additional Manufacturer Narrative
Device technical analysis: visual inspection of the returned lead adapter revealed cables # 1 and 2 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.The complaint of high impedances was confirmed through product analysis.The probable cause was traced to component failure correction to initial mdr in fields d4 and b5.
Event or Problem Description
It was reported that the ipg was showing two high impedances on two therapeutic contacts, and it was causing inadequate stimulation for the patient.The stimulation was turned off as the physician opened patient up at the head site to test the lead, and pocket site to test the extension and adaptors.Physician assessed one of the adapters was broken.He replaced the broken adaptor with a new one.The patient was doing good post operatively and receiving good stimulation coverage.Additional information was received when the device was returned on 07apr2020 that the serial number of the explanted device is (b)(6) and not (b)(6) that was reported in the initial vigilance report.

• 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: 9771006
• Report Number: 3006630150-2020-00866
• Device Sequence Number: 2574675
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 02/11/2021
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7041996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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