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

Model Number	37704
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Electric Shock (2554)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient was getting a jolt when working with the patient programmer.The caller was worried that it was too high and wanted to ensure that the patient would not get a shock.This had happened a couple of times and a manufacturer representative was informed about it when manufacturer representative had met with the patient on friday ((b)(6) 2016).Additional information was received from a consumer reporting that with troubleshooting they were able to use the patient programmer to connect, lower amplitude, and turn the implantable neurostimulator (ins) on.It was reviewed to set stimulation at a comfortable level.
Event or Problem Description
Additional information was received from a health care professional (hcp) on (b)(6) 2016 reporting that the device was interrogated by a manufacturer representative on (b)(6) 2016.No further action was necessary.The cause of the jolts was not determined.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6124088
• Report Number: 3004209178-2016-24615
• Device Sequence Number: 19010368
• Product Code: LGW
• UDI-Device Identifier: 00643169107809
• UDI-Public: 00643169107809
• Combination Product (Y/N): N
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2016

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: 12/28/2016
• Device Model Number: 37704
• Device Catalogue Number: 37704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided; 12/09/2016
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 12/09/2016; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1