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

Model Number	DB-1110-C
Medical Device Problem Codes	High impedance (1291); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient had trouble fully charging their sub clavicular implantable pulse generator (ipg), resulting in frequent charging attempts.Additional training and charging cycles were performed but did not resolve the issue.Data log analysis identified high impedance on one contact, frequent charging cycles, and consistent interruption of charging at 3.8v.Analysis also showed interruptions and low charge current, suggesting suboptimal charger to ipg alignment, a potential charger malfunction, or activation of the thermistor during charging.Engineering was unable to determine a definitive root cause.They recommended that the patient allow the ipg to discharge below 3.8v and then perform a two hour charge cycle until the double beep confirmation is reached.The patient was admitted for further evaluation and remains under the care of their physician.The ipg remains implanted, and no stimulation issues have been reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Section b3: exact date unknown, event occurred in july2021.
Additional Manufacturer Narrative
Section b5 describe event or problem event description has been updated.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient had trouble fully charging their sub clavicular implantable pulse generator (ipg), resulting in frequent charging attempts.Additional training and charging cycles were performed but did not resolve the issue.Data log analysis identified high impedance on one contact, frequent charging cycles, and consistent interruption of charging at 3.8v.Analysis also showed interruptions and low charge current, suggesting suboptimal charger to ipg alignment, a potential charger malfunction, or activation of the thermistor during charging.Engineering was unable to determine a definitive root cause.They recommended that the patient allow the ipg to discharge below 3.8v and then perform a two hour charge cycle until the double beep confirmation is reached.The patient was admitted for further evaluation and remains under the care of their physician.The ipg remains implanted, and no stimulation issues have been reported.Additional information received confirmed no surgical or medical intervention was performed during hospitalization and charging issues have been resolved through additional training.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient had trouble fully charging their sub clavicular implantable pulse generator (ipg), resulting in frequent charging attempts.Additional training and charging cycles were performed but did not resolve the issue.Data log analysis identified high impedance on one contact, frequent charging cycles, and consistent interruption of charging at 3.8v.Analysis also showed interruptions and low charge current, suggesting suboptimal charger to ipg alignment, a potential charger malfunction, or activation of the thermistor during charging.Engineering was unable to determine a definitive root cause.They recommended that the patient allow the ipg to discharge below 3.8v and then perform a two hour charge cycle until the double beep confirmation is reached.The patient was admitted for further evaluation and remains under the care of their physician.The ipg remains implanted, and no stimulation issues have been reported.Additional information received confirmed no surgical or medical intervention was performed during hospitalization and charging issues have been resolved through additional training.
Additional Manufacturer Narrative
With all the available information (in the absence of product return), boston scientific has concluded that inability to fully charge and difficulties charging implantable pulse generators (ipg) root cause could not be established.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the ifu product label.However, a data analysis review confirmed that the ipg was not charged to 3 bars as far back to middle of july 2021 and charge has consistently stopped when the ipg is 3.8v just short of the 3.9v that indicates a full charge.Additionally, data analysis confirmed that the charging frequency had decreased while the charging duration remained the same.A risk review confirmed that inability to fully charge, difficulties charging ipg were defined in the documentation.The ipg remains implanted, and as such, physical analysis has not been conducted in our laboratory.However, based on objective evidence from the field and the labeling review, engineers could not determine the root cause of the reported event and concluded that the cause not be established.

• Brand Name: VERCISE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24613814
• Report Number: 3006630150-2026-01547
• Device Sequence Number: 9834423
• Product Code: NHL
• 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 Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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: 02/28/2019
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 20338730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 05/04/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/14/2026; 06/03/2026
• Date Device Manufactured: 02/28/2017
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Unknown