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

Model Number DB-1110C

Device Problems Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591)

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

Event Date 02/22/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced loss of therapy and could not move.The implantable pulse generator (ipg) communication generated error codes with the remote control and clinician programmers.The patient's symptoms were due to advanced parkinson's disease which worsened because the stimulation was turned off.The neurologist increased the amount of carbidopa levodopa, and sinemet the patient was taking due to the stimulation being off and the patient underwent an ipg replacement procedure.The patient was doing well post-operatively.

Event Description

It was reported that the patient experienced loss of therapy and could not move.The implantable pulse generator (ipg) communication generated error codes with the remote control and clinician programmers.The patient's symptoms were due to advanced parkinson's disease which worsened because the stimulation was turned off.The neurologist increased the amount of carbidopa levodopa, and sinemet the patient was taking due to the stimulation being off and the patient underwent an ipg replacement procedure.The patient was doing well post-operatively.

Manufacturer Narrative

With all the available information, boston scientific corporation concludes that the complaint was confirmed.Analysis of the returned ipg revealed an application code segment crc error in the flash memory.When monitoring the patient's simulation output signal on an oscilloscope, no signal was detected on all electrodes.Some electronics of the device had been damaged by an external force such as high voltage transient.The investigation concluded that a review of the patient's profile showed no sign of device damage prior to the explant.This evidence suggested that some electronics had been damaged by an external force such as high voltage transient, and the device was unable to provide effective therapy to the patient.The probable cause is traced to component failure.

• 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: 11544909
• MDR Text Key: 241539984
• Report Number: 3006630150-2021-01137
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2020
• Device Model Number: DB-1110C
• Device Catalogue Number: DB-1110C
• Device Lot Number: 21587972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR