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

Model Number DB-1216

Device Problems Overheating of Device (1437); Unexpected Therapeutic Results (1631); Charging Problem (2892)

Patient Problems Bruise/Contusion (1754); Burning Sensation (2146); Discomfort (2330); Respiratory Insufficiency (4462); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 04/16/2021

Event Type  Injury  

Event Description

It was reported the patient implanted with the deep brain stimulation (dbs) system experienced a non-device related fall onto her chest and neck resulting in swelling and bruising.Soon after, the patient also experienced stridor and vocal cord dysfunction resulting in multiple hospitalizations including admission into the intensive care unit (icu).The physician initially assessed that due to the placement of the implantable pulse generator (ipg) near the clavicle, the fall may have damaged the ipg causing unwanted stimulation of the vagal nerve, thereby contributing to her respiratory distress.X-ray imaging taken in the field confirmed the leads were intact and were not displaced by the fall; a head computerized tomography (ct) scan was negative for bleeding.Additionally, as the patient continued to experience episodes of respiratory distress, it was found that the occurrence of these events would happen with and without stimulation turned on.The patient also reported being unable to fully charge the ipg, and while charging she experienced burning and shocking sensations at the ipg site that incited breathing difficulty.The patient's medication has been adjusted.

Manufacturer Narrative

Date of event: exact date unknown, event occurred in april 2021.

• Brand Name: VERCISE GENUS
• 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: 15667223
• MDR Text Key: 302350245
• Report Number: 3006630150-2022-05754
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: Physician
• Type of Report: Initial
• Report Date: 10/25/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 505639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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): Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Race: White