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

Model Number	37703
Medical Device Problem Codes	Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that the pt stated that sometimes when they pass by computers or dialysis machines, or when they are near the air force base by where they live, their ins turns off and they get electrocuted.Pt clarified that they don't actually get electrocuted, but that it feels like a static shock.Pt said they have also experienced this when going through security and they have learned to turn their ins off.Pt said this has been going on since they had their first implant in 1999.The patient was directed to follow-up with their healthcare provider.
Additional Manufacturer Narrative
Concomitant medical products: product id 7425, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2015, product type implantable neurostimulator, product id 7425, lot# serial# (b)(4) implanted: (b)(6) 1999-, product type implantable neurostimulator.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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12791159
• Report Number: 3004209178-2021-16808
• Device Sequence Number: 4005262
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/10/2021

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: 11/28/2015
• 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: 11/09/2021
• Initial Report FDA Received Date: 11/10/2021
• Date Device Manufactured: 05/29/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female