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 Migration or Expulsion of Device (1395); Overheating of Device (1437); Charging Problem (2892); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

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) for spinal pain.The patient reports that beginning maybe a year ago their ins needs to be repositioned because it is working its way through the skin more or less.The patient actually wants to have it removed because they do not want to go through another surgery again.The patient indicated that their healthcare professional (hcp) is no longer working at the hospital where they had it implanted so they need a list of hcps in the area they can contact.This was considered a gradual change in therapy/symptoms.No further complications were reported/are anticipated.Additional information was received from a consumer regarding the patient.The patient clarified the report of ¿it working its way through the skin¿ by stating that the implant had moved and now would not work because it would not charge.The patient stated they contacted their doctor regarding the issue.The patient did not know their weight at the time of the event nor the status of the affected device.They stated that the issue had not been resolved yet.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the patient on (b)(6) 2018.When asked to clarify it working through their skin more or less the patient stated that it moved out of place and is now too close to their skin which hurts.The patient does not know their weight at the time of the event.The patient indicated that their device is not working and it got too hot to charge.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
• 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: 7662469
• MDR Text Key: 113186618
• Report Number: 3004209178-2018-15006
• 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
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/05/2013
• 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: 61 YR