MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SURETEK; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number DB-4600C

Device Problem Defective Device (2588)

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

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect device.Model db-4600c; suretek bur hole cover kit; lot: 22537546.The device is not expected to be returned as the portion of the screw was left implanted in the patient, therefore a technical product analysis cannot be carried out.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.

Event Description

A report was received that during a procedure a burr hole screw broke in half.The head which is the top part broke off from the bottom part with the threads.The bottom half was left inside the patients skull as the physician did not want to drill it out.There were two burr hold cover kits used and it is not known which kit is associated with this event.

• Brand Name: SURETEK
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 9072267
• MDR Text Key: 158710991
• Report Number: 3006630150-2019-05066
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: 08714729820802
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2020
• Device Model Number: DB-4600C
• Device Catalogue Number: DB-4600C
• Device Lot Number: 22606115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2018
• 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): Other