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

Model Number	37703
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date inaccurate, only the month and year are valid.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding an implantable neurostimulator (ins) for non-malignant pain and post lumbar laminectomy syndrome.It was reported that the patient thought something was wrong with their programmer- when they went to turn stimulation off at night (and confirmed the lightning bolt disappeared) the stimulation continued; this occurred daily.The patient knew how to use the device and their healthcare provider (hcp) suggested they get their programmer replaced.The patient called back after receiving their replacement device and reported that it still wasn't working.No further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a healthcare professional (hcp).It was reported that the patient had a clinical assessment coming up.No further complications were reported.

• Brand Name: ITREL 4
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8816378
• Report Number: 3004209178-2019-14027
• Device Sequence Number: 2838654
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 11/14/2016
• 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: 06/26/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR