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

Model Number DB-1110C

Device Problems Device Issue (2379); Communication or Transmission Problem (2896)

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

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that during the patient programming, the physician could not query the impedances of the ipg.Ipg database analysis was performed and the error was confirmed.The patient underwent an ipg replacement and was subsequently reprogrammed.The patient is post-operatively doing well.

• 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: 7242827
• MDR Text Key: 99099264
• Report Number: 3006630150-2018-00417
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 02/05/2018

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: 12/14/2017
• Device Model Number: DB-1110C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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 Age: 58 YR