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

Model Number DB-9218-15

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Event 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 Description

A report was received that the patient was experiencing impedance issues on one electrode of the m8 adapter.The physician replaced the adapter.

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 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
• 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: 7478112
• MDR Text Key: 107080491
• Report Number: 3006630150-2018-01516
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 05/07/2018; 05/31/2018
• Supplement Dates FDA Received: 05/24/2018; 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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