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

Model Number	37701
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2017
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 manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of radiculopathy and spinal pain.It was reported that patient has an impedance issue.It was reported that the contact 7 8 9 10 11 12 and 15 are all over 3600 ohms.It was reviewed that over 3600 ohms may indicate that an open circuit.The rep attempted to reprogram around these electrodes, but the patient preferred their initial settings, so the caller would return to the initial settings.No further complications were reported or anticipated.No symptoms were reported.Additional information was received from the rep.It was reported that there was a replacement which was believed to be due to normal battery depletion.The hcp decided to do a full system replacement because a lead was possibly fractured.Replacement was done in 2018 however issue found in 2017.The rep then confirmed that the reason for replacement was actually due to the initial complaint of impedance issues and not lead fracture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE PRIME
• 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 00777
• MDR Report Key: 9331047
• Report Number: 3004209178-2019-21929
• Device Sequence Number: 11323841
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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 Age: 44 YR