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

Model Number DB-9218-15

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

Lead extensions were connected to the adaptors that were plugged into the new internal pulse generator.Impedance check showed appropriate connectivity.The connection was secured with a torque wrench and the pulse generator was placed in the subclavicular pocket and closed with suture.Impedance was again verified, and abnormal impedance was noted.The subclavicular pocket was opened and the adaptors were switched out.Per the surgeon this appeared to be an intermittent break with the medtronic extensions with which he is very familiar.

Event Description

Lead extensions were connected to the adaptors that were plugged into the new internal pulse generator.Impedance check showed appropriate connectivity.The connection was secured with a torque wrench and the pulse generator was placed in the subclavicular pocket and closed with suture.Impedance was again verified, and abnormal impedance was noted.The subclavicular pocket was opened and the adaptors were switched out.Per the surgeon this appeared to be an intermittent break with the medtronic extensions with which he is very familiar.

• Brand Name: VERCISE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10634234
• MDR Text Key: 210019111
• Report Number: 10634234
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2020,09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28105 DA
• Patient Weight: 104