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

Model Number DB-1216

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Intermittent Energy Output (4025)

Patient Problems Undesired Nerve Stimulation (1980); Dizziness (2194); Numbness (2415); Speech Disorder (4415)

Event Date 03/16/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced intermittent stimulation, shocking sensation, dizziness, slurred speech, and the patients face and arms felt numb.The patient was admitted to the emergency room.Electrocardiogram (ekg), computerized tomography (ct) scan, and blood pressure results were normal and the patient was stable.The stimulation which had been turned off was turned back on at a lower setting.An impedance check showed no anomalies and patient was later released from the emergency room.

Event Description

It was reported that the patient experienced intermittent stimulation, shocking sensation, dizziness, slurred speech, and the patients face and arms felt numb.The patient was admitted to the emergency room.Electrocardiogram (ekg), computerized tomography (ct) scan, and blood pressure results were normal and the patient was stable.The stimulation which had been turned off was turned back on at a lower setting.An impedance check showed no anomalies and patient was later released from the emergency room.Additional information was received that a database analysis revealed no anomalies with the ipg.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14001993
• MDR Text Key: 288583038
• Report Number: 3006630150-2022-01455
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 510068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male