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

Model Number DB-1200-S

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

It was reported that during a deep brain stimulation procedure to implant the right side lead to the already implanted battery, the surgeon was unable to close and tighten the set screws on the ipg.The set screw would not engage with the driver and the port set screw was unable to be tightened down to secure the new lead extension in place.The ipg was replaced and the lead extension was then able to be secured in the ipg port.

Event Description

It was reported that during a deep brain stimulation procedure to implant the right side lead to the already implanted battery, the surgeon was unable to close and tighten the set screws on the ipg.The set screw would not engage with the driver and the port set screw was unable to be tightened down to secure the lead extension in place.The ipg was replaced and the lead extension was then able to be secured in the ipg port.

Manufacturer Narrative

The returned ipg was analyzed and found that the setscrew in port c was covered with silicon debris broken off the septum which caused the hex driver not to engage with the setscrew.After clearing the debris, the hex wrench was able to turn the setscrew to lock and unlock a lead.With the available information, boston scientific has determined the probable cause of the event was due the an unintended use error during the procedure.

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11530676
• MDR Text Key: 241382150
• Report Number: 3006630150-2021-01101
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR