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

Model Number	37713
Medical Device Problem Codes	Battery Problem (2885); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for complex reg pain syndrome type i and spinal pain.The reason for call was to get mri information.The caller indicated that the implanted battery is dead and the patient lost remote.When asked for additional details the caller provided the following information, when the patient was implanted they had issues with the implanted device and it was hurting his chest.Another neurosurgeon told the patient not to use the device.Troubleshooting was not required.Additional information received from the patient.The reason for call was pt mentioned their "stimulator battery was not working" since 3 years ago.Pt said the spinal cord stimulator(scs) has not worked for some time and they wanted to get the scs removed because they had problems related to the scs in the past.Pt said they had a hard time finding an hcp who would remove scs, but the pt eventually found dr.(b)(6), who talked to the pt and said the scs would be difficult to remove completely and would cause problems, but discussed the possibility of replacing the scs with another newer model.Pt elected to have a replacement surgery on (b)(6) 2022.Pt said they needed a mdt rep.To call them to ensure they would be head-only eligible after the surgery.Pt said they had strokes in the past and would need an mri of their head if they had strokes in the future and the hcps needed to see how much damage was done.Patient services specialist(pss) reviewed the mri compatibility guidelines for the pt if their implanted neurostimulator(ins) was replaced, but not their leads with both vanta and intellis.Pt still insisted a mdt rep.Call them and discuss with them the mri eligibility status of their newly implanted ins once they have surgery.Pt's hcp, dr.(b)(6) told the pt they would fix the pt's back after the surgery.Pt had several discs that were herniated and one disc that was ruptured and pressing on a nerve.Pt said "it was getting to the point where it was hard to bend over" and pt had numbness in legs when bending over and intense pain.Pss emailed the local mdt reps.Pss documenting reported event.

• Brand Name: RESTORE ADVANCED
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14601659
• Report Number: 3004209178-2022-07190
• Device Sequence Number: 5041645
• Product Code: LGW
• UDI-Device Identifier: 00613994842367
• UDI-Public: 00613994842367
• Combination Product (Y/N): N
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/06/2022
• Date Device Manufactured: 03/04/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male