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

Model Number	37712
Medical Device Problem Codes	Battery Problem (2885); Charging Problem (2892)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was a while ago the pts ins went out (pt did not clarify why the ins went out), pt stated that the ins no longer worked to take a charge and it was completely depleted.Pt said the scs was not operational.The pts hcp wanted to replace the ins with the newer version.No patient symptoms reported.Additional information was received from the patient.They reported that the same issue, and they are trying to get an ins replacement but the procedure was cancelled and they want to know why.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient reported that their implant battery did not last as long as they were told it would last, it did not last 7 years.Patient reported that they want and need to get a new implant battery but that they cannot; patient added that the manufacturer called them and told them about a new battery and they were interested.Patient mentioned that they were looking forward to having the implant replaced, but the manufacturer would only accept so much for the battery.Patient also mentioned that the center would only pay so much and the manufacturer would not accept what the center wanted to pay for the implant.Patient noted that they have medicare and so they can only pay and do so much for the replacement.Patient mentioned that manufacturer will not meet the center at a reasonable price for the replacement battery and that the patient is very upset.Patient also mentioned that the nurse at the center has been trying to get in contact with the manufacturer and has been hitting a brick wall.Agent reviewed that the sales reps are the negotiators with the doctors and that they have more information on the sales of equipment.Agent offered and sent an email to the field.When asked for an event date; patient noted that their implant did not last 7 years, they had used the device and then had [unrelated] surgery and thought they would not need the device but the pain came back and they tried to reboot the device but it never came back on.When asked for a managing hcp; patient mentioned that their old doctor left the practice and they now work with a neurosurgeon.The patient was redirected to their healthcare provider to further address the issue.On 2024-aug-01 patient added that they have been trying to get this resolved since 2021.

• Brand Name: RESTORE ULTRA
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19616629
• Report Number: 3004209178-2024-13620
• Device Sequence Number: 12506021
• Product Code: LGW
• UDI-Device Identifier: 00613994842343
• UDI-Public: 00613994842343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/28/2024
• Date Device Manufactured: 05/02/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female