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

Model Number	DB-1216
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Bradycardia (1751); Fall (1848); Shaking/Tremors (2515); Unspecified Musculoskeletal problem (4535)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient that is implanted with the deep brain stimulation (dbs) system experienced difficulty charging of the implantable pulse generator (ipg) causing a loss of stimulation, the return of their pre-existing parkinson's disease symptoms of tremor, rigidity and bradykinesia, and the remote control would not connect to the ipg.The patient was provided with charging education and was able to charge the ipg, got it out of hibernation and was able to reconnect the remote control.The patient stated that they fell a few months ago onto the ipg pocket site, after which the physician examined the ipg pocket site, imaging was performed and no irregularities were identified.The patient underwent an ipg replacement procedure, therapy has been restored and is doing well post operatively.
Additional Manufacturer Narrative
Correction to the following blocks: d2b pro code: mhy.E3: occupation.G1: mfr contact phone number, mfr contact email.

• 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: 50862389
• Report Number: 3006630150-2026-07008
• Device Sequence Number: 13268365
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)270417(10)790631
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 790631
• 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: 08/24/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/17/2025
• 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