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

Model Number DB-1200-S

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

Patient Problem Pocket Erosion (2013)

Event Date 08/16/2022

Event Type  Injury  

Event Description

It was reported by the patients mother that the patients deep brain stimulator (dbs) implantable pulse generator (ipg) was starting to erode out of her skin.The patient was seen by the neurosurgery team and given topical antibiotics and the implant site was bandaged.The incision site has healed up to the point where there is no exposure of the ipg through the skin and the patient is receiving adequate therapy.After review of the ipg battery charge, it was found that the patients ipg had been completely drained throughout the month of (b)(6) 2022 to the point that no dots were visible.The patient began charging again at the start of (b)(6) 2022 and had charged several times to get up ipg back up to normal range.

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15592367
• MDR Text Key: 301625504
• Report Number: 3006630150-2022-05481
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 741689
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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: 14 YR
• Patient Sex: Female