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

Model Number	37712
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A correction was made to update the most accurate information regarding the reported device.If information is provided in the future, a supplemental report will be issued.
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 (hcp) regarding a patient's implantable neurostimulator (ins).It was reported that they were calling from the hospital because the patient went to the emergency room and the equipment had an alert to seek medical care so they were trying to find a facility to remove the ins.The caller confirmed that the patient's emergency room visit is related to the mdt device/therapy; patient services clarified further with the caller and caller states that the device alerted; alert on pain stimulator to seek medical care.No patient symptoms reported.No further complications reported/anticipated.Additional information was received from the patient.It was reported that the battery charger showed that they "needed to go to the er".Patient likely meant it was showing eri.Patient reported the device indicated it was necessary.Patient stated they also had medical issues that required an mri.Patient stated they need surgery and may get another one.Patient reported they will removing it and their next appointment was on (b)(6) 2020.

• Brand Name: RESTORE ULTRA
• Common Device Name: 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 MN 00777
• MDR Report Key: 9949993
• Report Number: 2182208-2020-00705
• Device Sequence Number: 19615965
• Product Code: LGW
• UDI-Device Identifier: 00613994342935
• UDI-Public: 00613994342935
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 04/14/2012
• 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: 04/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 98