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

Model Number	DB-1232
Medical Device Problem Codes	Charging Problem (2892); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an implant procedure to implant new leads however, prior to the procedure the patient experienced difficulty charging the implantable pulse generator (ipg) out of hibernation mode and thus the ipg would not communicate with the remote control.Therefore, this ipg was explanted from the abdomen and replaced with a new ipg that was placed in the chest subcutaneously.As the lead extensions were locked into the ipg and unable to be removed, they were cut and a portion of the lead extensions remain implanted.There were no reported patient complications and the patient is stable postoperatively.
Additional Manufacturer Narrative
Block d2b: additional pro code selection that applies to the indication of this device additional product(s) in device system: model number/catalog number: db-3128-95 serial number: (b)(6), batch/lot number: n/i, model/catalog description: dbs 2x8 extension 95cm sterile kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-3128-95, serial number: (b)(6), batch/lot number: n/i, model/catalog description: dbs 2x8 extension 95cm sterile kit, unique identifier (udi) #: (b)(4).

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50284765
• Report Number: 3006630150-2026-05970
• Device Sequence Number: 9753362
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)230113(10)501913
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 01/13/2023
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 501913
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 01/13/2021
• 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 Sex: Unknown