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

Model Number DB-1110C

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Neurological Deficit/Dysfunction (1982); Paralysis (1997); Dyskinesia (2363); Cognitive Changes (2551); No Code Available (3191)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that device was turning off without any interference.The patient experienced loss of stimulation and as a result could not walk, eat, or go to the restroom without assistance.The patients medication was increased.The stimulation was turned back on and the symptoms improved.On occasion, the patient would become non-responsive and one would need to clap loudly in order for the patient to respond.A technical analysis was performed and revealed that the device had been turned off periodically during the month of november 2020, however the device was working as expected and no anomalies were detected.The physician made adjustments to the patients stimulation and medication and will continue to monitor the patient.

• Brand Name: VERCISE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10994701
• MDR Text Key: 221223393
• Report Number: 3006630150-2020-06163
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2019
• Device Model Number: DB-1110C
• Device Catalogue Number: DB-1110C
• Device Lot Number: 21264923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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): Required Intervention
• Patient Age: 71 YR