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

Model Number DB-1200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Emotional Changes (1831)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450 , model: db-2202-45, serial: (b)(4), batch: 7078516.Product family: dbs-linear leads, upn: m365db2202450 , model: db-2202-45, serial: (b)(4), batch: 7078340.

Event Description

It was reported that the day the device was activated, the clinical study patient developed a mild hypomania episode and affective complication.The device was reprogrammed and the patient was treated with medication.The patient has been referred for a psychiatry consultation.The physician assessed that the event was possibly related to the stimulation and was not related to the hardware or to the procedure.

Event Description

It was reported that the day the device was activated, the clinical study patient developed a mild hypomania episode and affective complication.The device was reprogrammed and the patient was treated with medication.The patient has been referred for a psychiatry consultation.The physician assessed that the event was possibly related to the stimulation and was not related to the hardware or to the procedure.Additional information was received that the event of affective complication is no longer a reported event.

• 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
• MDR Report Key: 12233091
• MDR Text Key: 263834943
• Report Number: 3006630150-2021-04072
• 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
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2023
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 746148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention