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

Model Number DB-9218-15

Device Problems Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Pain Relief (2388); No Code Available (3191)

Event Date 02/17/2020

Event Type  Injury  

Event 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.

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 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
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9771006
• MDR Text Key: 181826171
• Report Number: 3006630150-2020-00866
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention