BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4192197 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20137
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377745, LOT# J0555529V, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REPROGRAMMED THE DAY OF THE REPORT TO INCREASE STIMULATION IN THE BACK. THE PATIENT WAS RECEIVING STIMULATION EVERY THE PATIENT NEEDED IT AND IT WAS PROVIDING GOOD PAIN RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FEEL THE STIMULATION FROM THEIR NEW IMPLANTABLE NEUROSTIMULATOR (INS) IN THEIR BACK AS THEY DID PRIOR TO THE REPLACEMENT NOTED AS <(><<)>50% THERAPY RELIEF AT THE LOCATION OF THE LEAD COMPONENT. IMPEDANCE TESTING SHOWED THAT ELECTRODES #2 AND 7 HAD VALUES >10,000 OHMS. REPROGRAMMING WAS PERFORMED AS AN ACTION FOR THE EVENT ISSUE. THE CAUSE OF THE IMPEDANCE ISSUE HAD NOT BEEN DETERMINED NOR HAD NOT IT RESOLVED. ANOTHER MANUFACTURER¿S REPRESENTATIVE THEN MET WITH THE PATIENT ON (B)(6) 2014 WHERE ADDITIONAL REPROGRAMMING WAS PERFORMED BUT WAS UNABLE TO GET THE STIMULATION INTO THEIR BACK AREA AS BEFORE THE REPLACEMENT SURGERY. THE PATIENT WAS REFERRED BACK TO THEIR PHYSICIAN TO DISCUSS A LEAD REVISION. NO OTHER DETAILS OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT THE STIMULATION WAS NOT WORKING ¿IN THE AREA IT USED TO WORK IN¿ EVER SINCE THE NEW IMPLANT ON (B)(6) 2014. WHEN THE PATIENT HAD THE DEVICE BEFORE, IT WORKED FOR HER SPINE, BACK AND LEG; HOWEVER, AT THE TIME, ALL THAT WAS WORKING WAS ONLY IN THE LEFT LEG. IT WAS NOTED THAT THE PATIENT JUST WANTED IT TO BE RIGHT AND WAS PLANNING TO DO A REVISION. THE REPORTER STATED THAT THE PATIENT WAS SUFFERING AND HAD BEEN SINCE JULY (DUE TO VARIOUS ISSUES). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LEAD WAS ADDED TO THE PATIENT¿S CURRENT SYSTEM AND THEY WERE ABLE TO OBTAIN STIMULATION IN THE PATIENT¿S BACK WHERE SHE WAS NOT GETTING IT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673067 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention