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

Model Number	DB-6412-5US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Pain (1994); Numbness (2415)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that on three separate occasions the patient experienced multiple symptoms due to charging his ipg.The patient reported that within one minute of putting his charger on his ipg he has experienced pain and numbness from his feet to his entire body, cold sweats, slurred speech, a metal taste in his mouth, throat tightening, shortness of breath, and stroke like symptoms.The patient reported that the symptoms last for the remainder of the day but resolve by the next day.The patient's charger was replaced and he reported no issues with the new charger.
Additional Manufacturer Narrative
Additional information was received that the charger passed all investigational tests performed and was working as expected.
Event or Problem Description
A report was received that on three separate occasions the patient experienced multiple symptoms due to charging his ipg.The patient reported that within one minute of putting his charger on his ipg he has experienced pain and numbness from his feet to his entire body, cold sweats, slurred speech, a metal taste in his mouth, throat tightening, shortness of breath, and stroke like symptoms.The patient reported that the symptoms last for the remainder of the day but resolve by the next day.The patient's charger was replaced and he reported no issues with the new charger.

• 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: 8031262
• Report Number: 3006630150-2018-61626
• Device Sequence Number: 16459463
• Product Code: MHY
• UDI-Device Identifier: 08714729965848
• UDI-Public: 08714729965848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: DB-6412-5US
• Device Catalogue Number: DB-6412-5US
• Device Lot Number: 21225457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 01/28/2019
• 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: Required Intervention