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

Model Number DB-1200-S

Device Problems Defective Alarm (1014); Inadequate or Insufficient Training (1643); Charging Problem (2892)

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

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing difficultly charging the implantable pulse generator ipg.The ipg was not reaching a full charge of three bars, and the patients tremors would return at one bar of battery life.The patient was instructed to keep the charger on the ipg even if the eoc end of charge alert beeps are heard and to turn on the charger if the led light turns off.The patient followed the instructions and was able to reach two bars of charged battery life.The patient later visited the clinic and attempts were made to charge the ipg.The patient was unable to charge the ipg for longer than 10 minutes.A magnet reset was performed but was unsuccessful in resolving the issue.Database analysis was performed and found no anomalies with the ipg.The physician decided to replace the ipg.The patient underwent a revision procedure to replace the ipg.The patient was noted to be stable post operatively.

Manufacturer Narrative

Correction to block d4: serial number.

Event Description

It was reported that the patient was experiencing difficultly charging the implantable pulse generator ipg.The ipg was not reaching a full charge of three bars, and the patients tremors would return at one bar of battery life.The patient was instructed to keep the charger on the ipg even if the eoc end of charge alert beeps are heard and to turn on the charger if the led light turns off.The patient followed the instructions and was able to reach two bars of charged battery life.The patient later visited the clinic and attempts were made to charge the ipg.The patient was unable to charge the ipg for longer than 10 minutes.A magnet reset was performed but was unsuccessful in resolving the issue.Database analysis was performed and found no anomalies with the ipg.The physician decided to replace the ipg.The patient underwent a revision procedure to replace the ipg.The patient was noted to be stable post operatively.Boston scientific subsequently received additional information indicating the serial number initially reported for the ipg was incorrect.The correct serial number of the explanted ipg is (b)(6) and has been updated.

Manufacturer Narrative

The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.The investigation concluded that the reported event of difficulty charging the ipg to achieve a fully charged battery was not confirmed.The device passed all tests performed, and exhibited normal device characteristics.Therefore, no problem was detected with this ipg.

Event Description

It was reported that the patient was experiencing difficultly charging the implantable pulse generator ipg.The ipg was not reaching a full charge of three bars, and the patients tremors would return at one bar of battery life.The patient was instructed to keep the charger on the ipg even if the eoc end of charge alert beeps are heard and to turn on the charger if the led light turns off.The patient followed the instructions and was able to reach two bars of charged battery life.The patient later visited the clinic and attempts were made to charge the ipg.The patient was unable to charge the ipg for longer than 10 minutes.A magnet reset was performed but was unsuccessful in resolving the issue.Database analysis was performed and found no anomalies with the ipg.The physician decided to replace the ipg.The patient underwent a revision procedure to replace the ipg.The patient was noted to be stable post operatively.Boston scientific subsequently received additional information indicating the serial number initially reported for the ipg was incorrect.The correct serial number of the explanted ipg is (b)(6) and has been updated.

• 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: 12088899
• MDR Text Key: 261469419
• Report Number: 3006630150-2021-03329
• 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,Followup
• Report Date: 09/15/2021

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: Lay User/Patient
• Device Expiration Date: 01/06/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 741526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 09/10/2021
• Supplement Dates FDA Received: 09/08/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR