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

Model Number DB-1200

Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588)

Patient Problem Shaking/Tremors (2515)

Event Date 02/06/2021

Event Type  Injury  

Event Description

It was reported that post revision procedure to upgrade the implantable pulse generator ipg for a deep brain stimulation dbs patient the ipg was not providing adequate stimulation wherein the patients tremors were not reduced.The patient was monitored overnight as attempts were made to troubleshoot with various programming changes that were unsuccessful and it was assessed that symptoms did not improve at all.The ipg was replaced providing good stimulation and tremors were gone and the patient was stable.

Manufacturer Narrative

Device technical analysis: the returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: the investigation concluded that the reported event of the ipg not providing adequate stimulation was not confirmed.The monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes and operated normally.Therefore, no problem was detected with this ipg.

Event Description

It was reported that post revision procedure to upgrade the implantable pulse generator ipg for a deep brain stimulation dbs patient the ipg was not providing adequate stimulation wherein the patients tremors were not reduced.The patient was monitored overnight as attempts were made to troubleshoot with various programming changes that were unsuccessful and it was assessed that symptoms did not improve at all.The ipg was replaced providing good stimulation and tremors were gone and the patient was stable.

• Brand Name: VERCISE GEVIA
• 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: 11344989
• MDR Text Key: 232439075
• Report Number: 3006630150-2021-00547
• Device Sequence Number: 1
• Product Code: MHY
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2022
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 744205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention