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

Model Number	NM-5312
Medical Device Problem Codes	No Display/Image (1183); Charging Problem (2892)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was experiencing difficulty charging the ipg.The patient was admitted to the hospital for observation.The charger was replaced which resolved the event.
Event or Problem Description
It was reported that a patient was experiencing difficulty charging the ipg.The patient was admitted to the hospital for observation.The charger was replaced which resolved the event.
Additional Manufacturer Narrative
The returned charger was analyzed and the complaint was confirmed.A fuse was found to be blown, creating an open circuit that did not allow the charger to charge in the base station.The probable cause was traced to a component failure due to a blown/open fuse.

• Brand Name: VERCISE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10457145
• Report Number: 3006630150-2020-03691
• Device Sequence Number: 3903676
• Product Code: MHY
• UDI-Device Identifier: 08714729820956
• UDI-Public: 08714729820956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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 Model Number: NM-5312
• Device Catalogue Number: NM-5312
• Device Lot Number: 21419479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization