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

Model Number 37712

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

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 (pt) who was implanted with an implantable neurostimulator (ins).It was reported that their recharger (insr) and pt programmer are not able to communicate with ins in their back.Patient services (pss) asked when this issue started and pt said that it had been a while.Pt described seeing poor communication screen on pt programmer and reposition antenna screen on insr.Pt said that the reposition antenna screen shows on the insr first, but then they see what looks to be a screen that shows the implant is charging.Pt said they never saw any doctor screens or anything.Pss reviewed that date of implant and screens could be possible over-discharge or possible end of service.The issue was not resolved.No symptoms were reported.

Event Description

Caller is with patient b/c of need to get ins functional again.Caller reports the patient will have a replacement at some point but would like to get stim restored.Caller reported patient hasn't had stim in 3 years.Ins 2018 the patient moved away and then with covid situation he was reluctant to be seen.Reviewed od recovery process.Patient reported he had another od recovered in 2013 and went through this same process and system was functional following that.Patient stated he is getting the warning por message on the mystim and recharger.Patient stated the stimulation is very strong for him.Patient asked to meet with local rep in his area to turn off the therapy because the pp and recharger are not working.Ps reviewed the meaning of por and in order for the mystim and recharger to function normally the warning por message will need to be clear at a hcp ofc.Ps sent email to local reps in the area.Pt called from phone # 2.Pt stated they were just with a rep today.Ins is now fully charged but got warning por.Pt said they felt stim so much and could not control it.Pt wife said pt was bouncing all over the place when pt was trying to use their hands.Reviewed stim is off if ins is in por.Had pt confirm it was a warning por and had pt use the insr and pt confirmed there was no lightning bolt.Pt said they felt stim being on b/c he felt being electrocuted or zapped and they need to turn it off.Redirected to hcp or rep.Pt said they were going to contact the rep.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received.Rep indicated a different rep spoke with patient and eliminated the shocking.Issue resolved.Cause was unknown.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12703546
• MDR Text Key: 278546048
• Report Number: 3004209178-2021-15963
• Device Sequence Number: 1
• Product Code: LGW
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

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: 03/28/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/11/2021; 11/17/2021
• Supplement Dates FDA Received: 11/16/2021; 12/09/2021
• Date Device Manufactured: 05/10/2011
• 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 Sex: Male