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 Fall (1848); Bone Fracture(s) (1870); Cognitive Changes (2551); Confusion/ Disorientation (2553); Speech Disorder (4415)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family dbs-linear leads, upn m365db2202450, model db-2202-45, serial (b)(4), batch 5058738.Product family dbs-linear leads, upn m365db2202450, model db-2202-45, serial (b)(4), batch 7078090.

Event Description

It was reported that the patient fell and broke three of his ribs.The stimulation was turned on when the patient fell.It is unknown whether the fall was device related.The patient has had two x-rays without turning the stimulation off, and had an magnetic resonance imaging without putting the device into mri mode.Since the fall the patient has been suffering from hallucinations, confusion and slurring of speech.The physician does not know if the patients symptoms are device or stimulation related, and does not know the cause.The patient was hospitalized.The patients impedances were checked and all were confirmed normal.

Manufacturer Narrative

Additional suspect medical device components involved in the event product family dbs-linear leads upn m365db2202450 model db-2202-45 serial (b)(4) batch 5058738 product family dbs-linear leads upn m365db2202450 model db-2202-45 serial (b)(4) batch 7078090.

Event Description

It was reported that the patient fell and broke three of his ribs.The stimulation was turned on when the patient fell.It is unknown whether the fall was device related.The patient has had two x-rays without turning the stimulation off, and had an magnetic resonance imaging without putting the device into mri mode.Since the fall the patient has been suffering from hallucinations, confusion and slurring of speech.The physician does not know if the patient's symptoms are device or stimulation related, and does not know the cause.The patient was hospitalized.The patient's impedances were checked and all were confirmed normal.Additional information was received that the physician feels that the device is operating fine.The patient is doing well and there is no further course of action.

• 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: 12791341
• MDR Text Key: 280808756
• Report Number: 3006630150-2021-06362
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2023
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 746409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Patient Sex: Male