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

Model Number DB-1216

Device Problems Use of Device Problem (1670); Charging Problem (2892)

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

Event Date 05/04/2023

Event Type  Injury  

Event Description

It was reported that the patients deep brain stimulation (dbs) implantable pulse generator (ipg) no longer held a charge following a non-device related cardiac ablation procedure where the device had not been turned off.The physician identified through the patients charging history that there was a rapid discharge of the ipg which signified the ipg had sustained damage.The patient was advised to charge daily.

Manufacturer Narrative

Update to blocks b1, b5, d6b, h6.

Event Description

It was reported that the patients deep brain stimulation (dbs) implantable pulse generator (ipg) no longer held a charge following a non-device related cardiac ablation procedure where the device had not been turned off.The physician identified through the patients charging history that there was a rapid discharge of the ipg which signified the ipg had sustained damage.The patient was advised to charge daily.Additional information was received that the ipg database was analyzed which confirmed rapid depletion of the ipg following the non-device related cardiac ablation procedures.Based on the instruction for use, ifu, exposure to electrocautery could cause permanent damage to the stimulator.Additional information was received that the patient underwent an ipg replacement procedure and was doing fine postoperatively.The explanted ipg will not be returned as it was discarded by the medical facility.

Event Description

It was reported that the patients deep brain stimulation (dbs) implantable pulse generator (ipg) no longer held a charge following a non-device related cardiac ablation procedure where the device had not been turned off.The physician identified through the patients charging history that there was a rapid discharge of the ipg which signified the ipg had sustained damage.The patient was advised to charge daily.Additional information was received that the ipg database was analyzed which confirmed rapid depletion of the ipg following the non-device related cardiac ablation procedures.Based on the instruction for use, ifu, exposure to electrocautery could cause permanent damage to the stimulator.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17140759
• MDR Text Key: 317674525
• Report Number: 3006630150-2023-03437
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

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: 11/16/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 526683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/18/2023; 09/14/2023
• Supplement Dates FDA Received: 07/12/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male