MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37713

Device Problems Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 02/01/2018

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 neuro stimulator (ins) for spinal pain.It was reported that this was second time the ins was starting to shoot massive pain through the pelvic and leg area.Patient wanted to change this with their remote and stop it going down leg and go down back.Patient stated they did not know this was coming from lower back until nerve health care professional (hcp) said it was coming from lower back.Hcp pressed stimulator and it hurt.It sent a bolt and "hurt like the diggings" down pelvic and leg area.Patient stated the first time it did this was a month ago from this report.Patient stated he would turn certain way and it would do this again.Patient did not know this was coming from the stimulator as he had such bad nerve damage.Patient reported no falls or trauma.Patient stated they no longer had a hcp.Patient stated the hcp wanted to stop his medication and patient stated he has to have his pain medication.Patient stated they wanted to stop this for a month however that was not going to work.Patient stated he had an appointment friday with his regular hcp who will help him find another hcp.Patient stated they cannot turn up because it was bad in the pelvic area.Patient stated he went to 0 but stimulation was still in the leg.Patient thought this was fixed but it was doing it all over again.Patient could feel this going through pelvic to leg even with no power.No further 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 patient.Patient said the reported issues just started happening.Patient previous health care professional (hcp) would not meet with them.The issues are still happening.Patient still does not have a pain dr.Yet still trying.No further patient symptoms or complications were reported in this event.

• Brand Name: RESTORE ADVANCED
• 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: 7373633
• MDR Text Key: 103827827
• Report Number: 3004209178-2018-05808
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842367
• UDI-Public: 00613994842367
• 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
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 06/12/2018
• Date Device Manufactured: 04/29/2013
• 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: 57 YR
• Patient Weight: 102