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 Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for an unknown dbs therapy.It was reported that pac man would not seat in base ring and close holding the lead in place.Actions taken to resolve the issue was get a new paceman and that didn¿t work.E used the toilet seat cap to secure.The issue was resolved.There were no symptoms reported.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.The cause of the pac man not holding the lead in place was not determined but could have been due to base ring not being seated correctly.Device information was provided.No patient weight was known.No further complications were reported as a result of this event.

• 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: 7533805
• MDR Text Key: 108902223
• Report Number: 3007566237-2018-01519
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 924256
• Device Catalogue Number: 924256
• Device Lot Number: 082216517A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• 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