MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for other chronic/intact pain (trunk/limbs) and spinal pain.It was reported that the patient could not get the settings back to what they used to be.The patient stated that the stimulation would go off on its own when they would sit or lay down.They reported it would come back on when they made a movement they did not usually make.The patient noted they were on high density (hd) settings for over a year, but they could not keep up with the charging, so they switched back.During the call, it was determined that the patient was on group d.The patient¿s adaptive stimulation (as) was noted to be on.The patient was redirected to follow up with a healthcare professional (hcp).No further complications were reported.Follow up was conducted.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) on 2018-jul-24.The hcp stated that the patient needs to meet with a manufacture representative (rep) to change the settings.An appointment was made for (b)(6) 2018 for the patient to come in and have the spinal cord stimulator (scs) adjusted.The patient¿s weight was unknown.No further complications were reported/are anticipated.

Manufacturer Narrative

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

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7714865
• MDR Text Key: 115075858
• Report Number: 3004209178-2018-16505
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR