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

Model Number NM-3138-55

Device Problem Malposition of Device (2616)

Patient Problem Discomfort (2330)

Event Date 01/18/2018

Event Type  Injury  

Event Description

A report was received that the patient underwent a lead revision procedure due to lead migration of the dbs leads.The left lead to extension connector was visibly raising the scalp and causing discomfort.During the revision, the connector at this site was found to be rotated in such a way that the screw block raised portion away from the skull towards the skin where the patient experienced discomfort.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: db-2201-45dc serial/lot: (b)(4) description: 45 cm twist lead, 0.016 tungsten stylet.

Event Description

A report was received that the patient underwent a lead revision procedure due to lead migration of the dbs leads.The left lead to extension connector was visibly raising the scalp and causing discomfort.During the revision, the connector at this site was found to be rotated in such a way that the screw block raised portion away from the skull towards the skin where the patient experienced discomfort.The physician dissected a periosteal layer below the connector and rotated and placed the connector deeper so that the screw block was no longer perpendicular to the skin.

• 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: 7244108
• MDR Text Key: 99122685
• Report Number: 3006630150-2018-00548
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2018
• Device Model Number: NM-3138-55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR