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); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Communication or Transmission Problem (2896); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Injury (2348)

Event Date 04/02/2018

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 manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for cervical radiculopathy and spinal pain.The rep reported that the ins was overdischarged.The rep reported that communication could not be established.The rep reported that they saw the patient on (b)(6) 2018 while the patient was in the hospital for congestive heart failure and no telemetry was possible with the clinician programmer.The rep reported that the patient didn¿t have the recharger available so communication with the recharger was unknown.The rep reported that they also saw the patient 3-4 weeks prior to the report while the patient was in the hospital but didn¿t attempt any communication because the patient was on a lot of medications and it wasn¿t a good time to try to do this.The rep reported that the patient last had stimulation on when she was admitted to the hospital about 3 months ag.The rep reported that stimulation was turned off at some point after the patient was admitted and hadn¿t been maintained since.The rep reported that they were going to consider options of either trying to recover the ins at some point in the future or replace the entire system.The rep reported that the patient did say that the stimulation therapy was helping her.No further complications were reported.Additional information received from the manufacturer representative reported that a trickle charge was done and the patient was reprogrammed.It was noted that the right lead did not seem to be working but the left lead was fine.Additional information received from the manufacturer representative reported that impedances were run and showed they were not working.No reason was determined for the lead issue.The representative was able to program the working lead and the patient was satisfied.The lead issue was not resolved and the healthcare provider was aware of the issue.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer via manufacturer representative.It was reported that the patient sustained medical injuries on 2018-jan-15 which resulted from the device.No further complications were reported or 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
• 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: 7542798
• MDR Text Key: 109364192
• Report Number: 3004209178-2018-11847
• 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,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2019
• Date Device Manufactured: 05/07/2013
• 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
• Patient Age: 68 YR
• Patient Weight: 66