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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Disconnection (1171); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that an out of regulation (oor) message displayed during normal use. The patient called the hcp on (b)(6) 2020 and was having an issue with their stimulation/remote. The patient had been in touch with the manufacturer out east and was told they thought one of the patient's leads came out. The hcp sent out for an x-ray in early march that showed that the leads were intact. The message the patient controller gave when turning voltage up or down was "settings not available. Cannot provide desired intensity settings. " the patient could turn stimulation on and off. It was noted that the patient called the manufacturer's patient services team. The issue was not resolved as of (b)(6) 2020. No surgical intervention occurred or was planned. No symptoms were reported, and the patient was alive with no injury. Additional information was received from the rep and hcp. It was reported that the cause of the oor message had not yet been determined as of (b)(6) 2020. They would interrogate/reprogram the patient once covid-19 restrictions have lifted. The implant date and serial number of the ins was provided.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, 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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10016267
MDR Text Key190564811
Report Number3004209178-2020-07954
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/18/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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