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 Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Refer to regulatory report # (b)(4).The patient had two implanted systems and it was not clear which issues pertained to which implanted system.The referenced report pertains to the patient¿s other system.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 for spinal cord stimulation - lumbar radiculopathy and spinal pain.It was reported that the patient there was poor communication.Patient reported that she was not able to charge one of her implants but did know which one was not charging.Patient reported last having stimulation a week ago and last having successfully charging a week ago.Patient stated she recharged every week.Troubleshooting occurred.Patient stated she had been doing all the troubleshooting and it was not doing anything.Patient stated she was not using the belt.Patient stated that the patient programmer showed the icon to charge implant.Patient stated she spoke with a manufacturer's representative about the issue and they have an appointment on (b)(6).Patient stated she was concerned because she has a surgery on (b)(6) for her hip.Caller was redirected to f/u with healthcare provider.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer via the manufacturer representative reported that the recharger was not functioning.The representative stated that the recharger would flash on and off and would not connect.When the representative tested with the recharger that they use there were no issues.The representative was going to request a replacement for the patient and the issue was resolved at the time of the report.

Manufacturer Narrative

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

Event Description

Additional information received from the rep reported that the cause of the recharger not working and screen flashing was not determined.The rep was told that someone from customer service would reach out to the patient directly to send them a new recharger.The rep had not been in contact with the patient and was unsure if they were sent a new recharger or not.No further complications were reported.

Manufacturer Narrative

References the main component of the system and other applicable components are: product id (b)(4) lot# serial# (b)(4) implanted: (b)(6) 2012 explanted: product type implantable neurostimulator product id(b)(4) lot# serial#(b)(4) implanted: ex planted: product type recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the patient¿s recharger was broken and needed to be replaced.The rep reported that the recharger wasn¿t working, so they looked at it and it was broken the screen just flashed and flashed.The rep reported that she gave the patient a loaner recharger.The rep was not with the patient at the time of the call.No further complications were reported.

• 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
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7154049
• MDR Text Key: 96124694
• Report Number: 3004209178-2017-26773
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Date Device Manufactured: 11/16/2011
• 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 Age: 72 YR