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

Model Number DB-1140

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Phone: (b)(6).

Event Description

A report was received that the patient, who is part of the (b)(6) clinical study developed a worsening of parkinson's disease which was moderate in severity.The patient was admitted and was treated with medication and device was reprogrammed.The patient and the are recovered and resolved, the patient was subsequently discharged.The event was reported with a possible relationship to stimulation and not related to procedure and hardware.

Manufacturer Narrative

Initial reporter's phone number: (b)(6).

Event Description

A report was received that the patient, who is part of the vercise dbs registry clinical study developed a worsening of parkinsons disease which was moderate in severity.The patient was admitted and was treated with medication and device was reprogrammed.The patient and the event are recovered and resolved, the patient was subsequently discharged.The event was reported with a possible relationship to stimulation and not related to procedure and hardware.Additional information was received that the event was reported with an unlikely relationship to the stimulation and not related to the procedure and hardware.Additional information was received that the patient was admitted with right emphasized bradykinetic and hypokinetic syndrome.

Manufacturer Narrative

Additional information was received that the event was reported with an unlikely relationship to the stimulation and not related to the procedure and hardware.

Event Description

A report was received that the patient, who is part of the vercise dbs registry clinical study developed a worsening of parkinson's disease which was moderate in severity.The patient was admitted and was treated with medication and device was reprogrammed.The patient and the are recovered and resolved, the patient was subsequently discharged.The event was reported with a possible relationship to stimulation and not related to procedure and hardware.

• Brand Name: VERCISE PC
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9398100
• MDR Text Key: 168706940
• Report Number: 3006630150-2019-06984
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/04/2017
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 18658774
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR