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

Model Number DB-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced irregular heartbeat and was admitted to the hospital for investigation.It is unknown if the irregular heartbeat is device related.

Manufacturer Narrative

Block h6 patient code: 3191: no code available is used as there is no corresponding fda code for additional intervention.

Event Description

It was reported that the patient experienced irregular heartbeat and was admitted to the hospital.It is unknown if the irregular heartbeat is device related.Additional information was received that the patients heart condition, irregular heartbeat, is unrelated to the dbs procedure.The patients heart condition was investigated, treated and he was discharged from the hospital.No further information has been obtained despite good faith efforts.

• 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: 10873221
• MDR Text Key: 217300017
• Report Number: 3006630150-2020-05711
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2022
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 744136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other