MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE; DEEP BRAIN STIMULATOR

Model Number DB-2201-45DC

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/03/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: db-2201-45dc serial #: (b)(4) description: 45cm lead kit model #: db-2201-45cm serial #: (b)(4) description: 45 cm twist lead, 0.016 tungsten stylet.

Event Description

A report was received that the patient developed slurring of speech and swallowing problems.The patient was administered medications and the device was reprogrammed.The event has resolved.The event was assessed as related to the stimulation and not related to the procedure or the hardware.

Manufacturer Narrative

Additional information was received that the event was also related to the device hardware.Additional suspect medical device component involved in the event: model #: db-1110 serial #: (b)(4) description: vercise ipg.

Event Description

A report was received that the patient developed slurring of speech and swallowing problems.The patient was administered medications and the device was reprogrammed.The event has resolved.The event was assessed as related to the stimulation and not related to the procedure or the hardware.

Manufacturer Narrative

Additional information was received that the dysphagia and dysarthria were assessed as not related to the device hardware.

Event Description

A report was received that the patient developed slurring of speech and swallowing problems.The patient was administered medications and the device was reprogrammed.The event has resolved.The event was assessed as related to the stimulation and not related to the procedure or the hardware.

• Brand Name: VERCISE
• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7448968
• MDR Text Key: 106131862
• Report Number: 3006630150-2018-01424
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2018

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: 07/21/2016
• Device Model Number: DB-2201-45DC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/10/2018; 06/04/2018
• Supplement Dates FDA Received: 05/11/2018; 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 47 YR