MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise Genus?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-1216
Medical Device Problem Codes	Use of Device Problem (1670); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a deep brain stimulation (dbs) patient underwent an implantable pulse generator (ipg) revision after the ipg battery was reported to no longer hold a charge.It was further reported that the patient had previously undergone shoulder surgery during which electrocautery was used and no protective measures were taken to protect the ipg.The physician stated that the ipg was most likely damaged during that procedure.The reported ipg was explanted and replaced with a new ipg.The patient was reported to be receiving therapy following the revision procedure.The location of the explanted device is unknown.
Additional Manufacturer Narrative
Block b3: approximated - event occurred a few weeks ago.Block d2b: additional applicable product codes: pjs, nhl.

• Brand Name: Vercise Genus?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50311691
• Report Number: 3006630150-2026-06031
• Device Sequence Number: 8770234
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)250617(10)576268
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/17/2025
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 576268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 09/13/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 06/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female