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

Model Number 924256

Device Problems Unstable (1667); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)

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

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported there was no patient issue.The surgeon was annoyed and thinks that the lead pulled up when the pac-man was closed.They think the pac-man did not secure the lead enough to pull it down from drive and not enough room to put cover on.The rep stated they did not attend the case on (b)(6) and it looked to them today, that the ring was not necessarily seated flush due to the rounding of the skull.Post-op ct showed that the lead was not in an ideal spot.Surgical intervention occurred.The surgeon opened the stim lock and pushed it down in 2 intervals today ((b)(6)) and confirmed placement with ct/that lead moved down.The issue was resolved.This is the second time the lead seems to pull up.The surgeon said they believe it is due to the poor closure of the stim lock pac-man.The rep covering the case on (b)(6) did hear the appropriate "clicks" to confirm that the stim lock was secure.

• Brand Name: STIMLOC
• Type of Device: COVER, BURR HOLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10106279
• MDR Text Key: 193285617
• Report Number: 2182207-2020-00283
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2020

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: Health Professional
• Device Model Number: 924256
• Device Catalogue Number: 924256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/01/2020
• 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: 60 YR