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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Insufficient Information (3190); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, product type: lead. Product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative (rep) concerning patient with an implantable neurostimulator (ins). It was reported the rep was initially able to interrogate device fine. The rep reported all they did was change from 565 to 2x8 paddle lead. After the change they saw an error code 0x530bfa59. It was suggested caller to clear out all history on the tablet, power the tablet off and power the communicator off twice. Caller reports when he tried to communicate with the ins again, a different error code occurred: system detected invalid data in the device, 0100850402010302000808000a0200. Exit and exit workflow did not resolve the issue. The rep tried connecting the cord to the communicator to the tablet did not resolve the issue. It was suggested the rep charge ins. Caller reports he had to do passive charge x4 and ins is now 80% charged. Communication to the ins with the controller works fine. Was able to charge and checked ins battery at 80%. Caller reports he did see a message: device not ready. It was reviewed that the ins has not been programmed, normal message. It was suggested caller disable and re-enable device. Caller reports that did not resolve the issue. Caller continues to see the same error message. Caller is going to try and find another tablet in the clinic. No further complications were reported/anticipated.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10240915
MDR Text Key198842435
Report Number2182207-2020-00487
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/07/2020 Patient Sequence Number: 1
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