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

Model Number DB-1200-S

Device Problems Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, patient complained of difficulty charging since being implanted (b)(6) 2019.The database analysis for the battery discharge and charge profile were observed and revealed no anomalies.However, there was indication of poor charger to ipg coupling causing intermittent charging of the ipg.Additionally, it was revealed that the reports of a shocking sensation were most likely caused by stimulation turning on after exiting out of hibernation mode.

Event Description

It was reported that the patient was having difficulty charging the ipg out of hibernation.Patient claimed that she was only able to attain one bar of charge after charging the ipg for 9 hours, and experienced a shocking sensation in her chest when stimulation turned on.The physician turned stimulation off and adjusted the patients medication.No further information has been obtained despite good faith efforts.

Event Description

It was reported that the patient was having difficulty charging the ipg out of hibernation.Patient claimed that she was only able to attain one bar of charge after 9 hours, and experienced a shocking sensation in her chest when stimulation was turned on.The physician has turned stimulation off and has adjusted the patients medication.Additional information was received that the patient was able to charge out of hibernation.

• 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
• MDR Report Key: 11425516
• MDR Text Key: 238600485
• Report Number: 3006630150-2021-00790
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739920
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR