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 Seroma (2069); Depression (2361)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(4), batch: (b)(4).

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced persistent decrease in psychomotor functions and intermittently inadequate social behavior.Due to persistence of these symptoms, further diagnostic examinations were necessary to exclude a primary organic cause.The patient was hospitalized to perform diagnostic examinations; a cerebral magnetic resonance imaging (mri) showed a dbs associated cystic lesion in the right ventral thalamic region.Computed tomography (ct) scan of the thorax and abdomen no malignancy was found.During an inpatient stay, a control cerebral mri was performed and showed a much smaller, regredient cystic lesion, so that a neurosurgical intervention was not necessary.In line with the regredience of the cystic lesion, psychomotor function and inadequate behavior also slightly improved.Interim clinical and imaging analysis shows marked improvement of signs and symptoms.A second cerebral mri was performed showing a completely resolved cyst as well as an improvement of psychomotor functioning.

• 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
• 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: 13205196
• MDR Text Key: 283490640
• Report Number: 3006630150-2021-07497
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2022
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 744665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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): Hospitalization