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

Model Number DB-9218-15

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

Patient Problems Muscular Rigidity (1968); Visual Impairment (2138); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Field b3 date of event: within the last year - 2017 additional suspect medical device component involved in the event: model #: db-1110c, serial #: (b)(4), description: vercise implantable pulse generator kit.

Event Description

A report was received that the patient experienced stiffness and numbness in the left arm and a light would appear in front of the patients eye when driving a car while backing up.In addition, the physician suspected a simple fracture was causing high impedances.The patient was hospitalized and underwent an explant procedure where the m8 adapter and ipg were removed.When the m8 adapter was removed, the impedances disappeared.The physician assessed that the symptoms of arm stiffness and light appearing in the eye may be due to the patient disease.

Manufacturer Narrative

Ipg db-1110c sn (b)(4) passed all required tests performed and revealed no anomalies.Lead db-9218-15 sn (b)(4): the complaint has been confirmed.Tests revealed that 2 cables were fractured at the connector.The fractured cables resulted in the reported high impedances.A review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient experienced stiffness and numbness in the left arm and a light would appear in front of the patients eye when driving a car while backing up.In addition, the physician suspected a simple fracture was causing high impedances.The patient was hospitalized and underwent an explant procedure where the m8 adapter and ipg were removed.When the m8 adapter was removed, the impedances disappeared.The physician assessed that the symptoms of arm stiffness and light appearing in the eye may be due to the patient disease.

• 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: 7384240
• MDR Text Key: 103909007
• Report Number: 3006630150-2018-01217
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2017
• Device Model Number: DB-9218-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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; Required Intervention