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

Model Number DB-1200

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/07/2018

Event Type  Injury  

Event Description

A report was received that the patient admitted due to worsening parkinsons disease symptoms which were severe.Per the physician assessment the patient demonstrated deterioration in parkinsons syndrome with increased tremor which is now also in the left hand, along with a speech disorder, deterioration in gait, and increased saliva flow.The patients device was reprogrammed and medication was adjusted.Per the physician the patient had significant improvement in speech pattern, better gait pattern, and slightly improving tremor.The event recovered and resolved with sequelae.The event was assessed as possibly related to the surgical procedure and not related to the stimulation and device.

Manufacturer Narrative

A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.

Event Description

A report was received that the patient admitted due to worsening parkinson's disease symptoms which were severe.Per the physician assessment the patient demonstrated deterioration in parkinson's syndrome with increased tremor which is now also in the left hand, along with a speech disorder, deterioration in gait, and increased saliva flow.The patients device was reprogrammed and medication was adjusted.Per the physician the patient had significant improvement in speech pattern, better gait pattern, and slightly improving tremor.The event recovered and resolved with sequelae.The event was assessed as possibly related to the surgical procedure and not related to the stimulation and device.

• Brand Name: VERCISE GEVIA
• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7715913
• MDR Text Key: 114889331
• Report Number: 3006630150-2018-60320
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2019
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 20787523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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): Hospitalization; Required Intervention