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); Therapy Delivered to Incorrect Body Area (1508); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 05/29/2018

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 patient with an implantable neurostimulator (ins) via a manufacturer representative.It was reported that the stimulation was no longer providing pain relief for the patient.The patient stated that they did not feel any stimulation.The patient noted that they do not use the patient programmer (pp) and they do not make any changes to the intensity.The patient was re-educated on how to use the pp and the stimulation was re-adjusted to perception and comfort.The patient was instructed to monitor their pain relief for 24 hours.The patient called back and reported that the stimulation was in their belly and it was not helping with their pain.The patent was instructed to set up an appointment with their healthcare provider (hcp) for reprogramming with a manufacturer representative.No further complications are anticipated.Additional information was received from the manufacturing representative (rep).It was reported that stimulation is still being felt by the patient just no in the areas of pain.At this point their assumption is that the device is still operating just not covering his pain areas.The cause of the belly stimulation is not determined patient has appointment on (b)(6).No actions/ intervention have occurred patient battery will be interrogated and perform impedance testing and try to reprogram.The issue has not been resolved at this time.Additional information was received from manufacturing representative (rep).It was reported that power on reset (por) code was seen.Rep reported that they were meeting with patient for possible reprogramming and patient programmer re-education.Rep interrogated ins with clinician programmer and saw power on reset (por) rep asked the patient further questions but patient never reported any issues with the device, stated they had been using it and had never been in overdischarge.Rep asked the patient if they had experienced loss of therapy or noticed the ins being off and patient said no.Rep indicated the patient actually grabbed their implantable neuro stimulator recharger (insr) and said they "use it all the time".Rep noted that the patient seemed confused about what they were reporting to the rep.Rep was confused as to how the patient could have come out of overdischarge since to the rep's knowledge, no one from manufacture had walked them through doing physician mode recharge.Por was successfully cleared.Rep said they saw message on clinician programmer indicating something about "battery has been discharged and this will affect his battery".Rep said they read ins first with clinician programmer, then interrogated ins with patient programmer and the programmer worked fine.Rep provided patient programmer education to patient.It was reviewed that pors can occur for reasons other than an overdischarge but from the message that the rep saw on clinician programmer it appears theins was in overdischarge.Patient did not allege any device or recharging issues prior to or even at the appointment.Rep saw the por today (b)(6) 2018.No patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacture representative (rep) on 2018-jun-21.The rep indicated that they contacted technical services regarding the issue because they did not know why the power on reset (por) messagewas appearing.The message was cleared and the patient was able to use the stimulation without any issues.The patient is still using the stimulation.Additional information was received from the rep on 2018-jul-02.It was determined that the patient had let the battery go into an overdischarge status.The stimulation issue was resolved with reprogramming.No cause was determined for the stimulation issues other than the patient did not like where the stimulation was programmed.The physician¿s office was notified that the complaint was resolved.No further action was needed.No further complications were reported/are anticipated.

• 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: 7587681
• MDR Text Key: 110707402
• Report Number: 3004209178-2018-13097
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2018
• Date Device Manufactured: 01/24/2013
• 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