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

Model Number DB-4600C

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670); Device Issue (2379)

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

Event Date 12/18/2017

Event Type  malfunction  

Event Description

A report was received that the dbs patient will undergo a lead revision procedure due to lead migration possibly caused by the slider being damaged or due to the improper fixation of the burr hole cover at the time of implant.

Manufacturer Narrative

Additional information was received that the patient underwent the revision procedure where the lead was removed and the burr hole retaining clip and cap were replaced.Upon explant of the devices, the surgeon acknowledged that the burr hole retention slider clip may have failed to lock due to not having been correctly checked during the implant procedure.User error was suspected.This event was also reported in mfr report #: 3006630150-2018-00083 additional suspect medical device component involved in the event: model #: db-2202-30, serial #: (b)(4), description: dbs directional lead sterile kit, 30cm.

Event Description

A report was received that the dbs patient will undergo a lead revision procedure due to lead migration possibly caused by the slider being damaged or due to the improper fixation of the burr hole cover at the time of implant.

Manufacturer Narrative

Correction to fu#1 mdr in field.The lead and base of the burr hole cover were not returned to bsn by the medical facility.The retaining clip and the cap from the burr hole cover were analyzed and the complaint was not confirmed.The device passed all required tests performed and exhibits normal device characteristics.

Event Description

A report was received that the dbs patient will undergo a lead revision procedure due to lead migration possibly caused by the slider being damaged or due to the improper fixation of the burr hole cover at the time of implant.

• 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: 7161756
• MDR Text Key: 96482353
• Report Number: 3006630150-2018-00012
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729820802
• UDI-Public: 08714729820802
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150031
• 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: 04/10/2018

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: 03/17/2019
• Device Model Number: DB-4600C
• Device Lot Number: 20331971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 02/12/2018; 03/27/2018
• Supplement Dates FDA Received: 02/28/2018; 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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