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 Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591); Battery Problem (2885); Data Problem (3196)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that an unknown error code appeared on the recharger when she went to charge.The patient kept trying to use and was eventually able to charge.The patient noted that the implant was off and she didn¿t think she had turned it off so she turned it on with the programmer.The programmer had a call your doctor message and the patient kept turning it off and on after the message appeared and was able to use the devices.Troubleshooting had the patient connect with both devices and the messages did not reappear.The patient mentioned she had gone to the theater the same day this occurred and they used a wand at security.The patient explained she went through metal detectors for work all the time and it doesn¿t set it off but this time it did.The patient was directed to their healthcare provider to check the implant further.The indication for use was non-malignant pain.Additional information was received from a consumer via a manufacturer's representative (rep) and a healthcare provider (hcp).It was reported that the circumstances that led to the error message and the implant being off unexpectedly was they were "wanded" (security wand) at the theater.The patient's device went off.The patient stated that it was weird as they work in a criminal court and go through metal detectors all the time.The patient met with the rep and it was in a por stated which was cleared.The patient stated that after it was reset the settings changed and it was giving them a zap that woke them up.The patient stated that it was different when they checked.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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).It was reported that the zapping was resolved when they turned the ins off.No further complications were reported or 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: 7707317
• MDR Text Key: 114805308
• Report Number: 3004209178-2018-16259
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/20/2012
• 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: 56 YR