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

Model Number	DB-9218-15
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that the patient was experiencing impedance issues on one electrode of the m8 adapter.The physician replaced the adapter.
Event or Problem Description
A report was received that the patient was experiencing impedance issues on one electrode of the m8 adapter.The physician replaced the adapter.
Additional Manufacturer Narrative
Additional information was received that the patient did not have any symptoms as a result of the high impedance.The patient was doing well post-operatively.Analysis of db-9218-15 (s/n (b)(4)) revealed that the complaint has been confirmed.Visual (microscope) and x-ray inspection found a broken cable (contact #1) at the connector block.There are no exposed cables.The broken cable resulted in the reported complaint of high impedance.A review of the manufacturing documentation for the device 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 was experiencing impedance issues on one electrode of the m8 adapter.The physician replaced the adapter.

• Brand Name: VERCISE DBS
• Common Device Name: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7478112
• Report Number: 3006630150-2018-01516
• Device Sequence Number: 19346025
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/15/2018
• Device Model Number: DB-9218-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/31/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/24/2018; 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1