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

Model Number DB-1140

Device Problems Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591); Wireless Communication Problem (3283)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 07/10/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing discomfort and inadequate stimulation.The nurse attempted to perform an impedance check and was unsuccessful due to communication issues with the ipg.The nurse then attempted a magnetic reset as advised by the boston scientific representative and was still unable to communicate with the ipg.The patient underwent a revision procedure to replace the ipg.The patient was doing well and fully recovered post operatively.

Manufacturer Narrative

Correction to field b5:description of event or problem device technical analysis this ipg was not functional when it was received in the lab it could not be charged nor could communication be established with either a remote control or clinical programmer.Internal electrical testing revealed excessive current leakage due to battery component damage associated with the asic application specific integrated circuit u1.The ipg battery was then removed and device data was captured using an external power source, which revealed a sudden battery voltage drop from 2.98 v to 2.65 v.Investigation conclusion review of this devices manufacturing documentation confirmed that this ipg passed all required specifications and testing prior to being released for distribution sale.It was reported that electrical diathermy was used during the implant procedure for this dbs ipg.Based on the results of laboratory testing and available information, engineers concluded that exposure to high frequency current associated with electrical diathermy likely caused electrical shorts within the ipgs asic u1.This circuitry damage resulted in the subsequent impact on device function inadequate stimulation and inability to communicate with the ipg.Therefore, the most reportable root cause was determined to be unintended use error caused or contributed to the event.

Event Description

It was reported that the patient implanted with this deep brain stimulator (dbs) system was experiencing discomfort and inadequate stimulation.A nurse attempted to perform an impedance check with the implantable pulse generator (ipg); however, communication could not be successfully established.A boston scientific representative advised performing a magnetic reset of the ipg, but this did not resolve the inability to communicate with the ipg.The patient underwent a revision procedure to replace the ipg.The patient was noted to be doing well following the procedure and fully recovered.Boston scientific subsequently received information indicating that electrical diathermy was used during the dbs ipg implant procedure.

• Brand Name: VERCISE PC
• 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: 10310593
• MDR Text Key: 199977402
• Report Number: 3006630150-2020-03037
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2021
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 632405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention