MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	37703
Medical Device Problem Codes	Battery Problem (2885); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
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 patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that around two days ago the patient's stimulation stopped working because eos (end of service) appeared.The patient noted that they thought they leaned against a magnet that caused the eos message to appear.The meaning of the screen was reviewed and the patient was redirected to follow-up with their healthcare provider (hcp).No symptoms were reported.

• Brand Name: ITREL 4
• 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: 10776062
• Report Number: 3004209178-2020-19153
• Device Sequence Number: 3385835
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: 01/28/2015
• Device Model Number: 37703
• Device Catalogue Number: 37703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR