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

Model Number	37703
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
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 spinal pain.It was reported that sometimes their ins works, sometimes it doesn't.Pt said they never turn the ins off, but they don't feel it working anymore.Pt said they have the ins on, but they are not feeling the vibrating in their back.Pt said that they can push it up to 9 but still can't feel it.When asked for event date, pt said it has been going off and on for most of this year; pt said lately the stimulator has been working but today it wasn't at all.The patient was redirected to their healthcare provider to further address the issue.  pt said they have been going to the pain clinic in starkville, ms and to their surgeon at the orthopedic clinic in (b)(6).The patient mentioned unrelated medical history including they had a fusion last september.Redirected caller: patient's hcp.

• Brand Name: ITREL 4
• 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
• MDR Report Key: 12540295
• Report Number: 3004209178-2021-14496
• Device Sequence Number: 4986260
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 03/28/2015
• 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: 09/21/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR