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

Model Number	DB-9218-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Visual Impairment (2138); Numbness (2415)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7384240
• Report Number: 3006630150-2018-01217
• Device Sequence Number: 1274250
• Product Code: NHL
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention