MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION STIMLOC; COVER, BURR HOLE

Model Number 924256

Device Problem Unstable (1667)

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

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient's undergoing implantation of bilateral deep brain stimulation (dbs).It was reported the burr hole cover cap did not snap into the stimloc burr hole coverto hold the lead in.No symptoms or complications were reported or anticipated.

• Brand Name: STIMLOC
• Type of Device: COVER, BURR HOLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8803030
• MDR Text Key: 151456032
• Report Number: 3007566237-2019-01592
• Device Sequence Number: 1
• Product Code: GXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 924256
• Device Catalogue Number: 924256
• Device Lot Number: 082233018A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2019
• Date Device Manufactured: 11/26/2018
• 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