BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5539555 · Received March 31, 2016

    Report

    Report Number
    3004209178-2016-05820
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Report Date
    April 1, 2016
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-56, LOT# V106106, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 3487A-56, LOT# V153177, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 377675, LOT# V010031, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. DEVICE ANALYSIS OF THE DESKTOP CHARGER REVEALED BROKEN CONNECTION PINS ON THE CABLE ASSEMBLY. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS NOT CHARGING AND THE CONNECTOR PIN WAS BROKEN. THE PATIENT TRIED TO SUPER GLUE BUT IT DID NOT WORK. THIS WAS NOTICED ABOUT A WEEK AND A HALF PRIOR TO THE REPORT AND THE RECHARGER HAD NOT BEEN RECHARGED SINCE. THE PATIENT STATED THE INS WAS DEAD AND THE PATIENT WAS GETTING THE EMPTY INS ICON. AS A RESULT THE PATIENT HAD NOT FELT STIMULATION (NO STIMULATION SENSATION) FOR FIVE DAYS FOR SURE, AND WAS IN PAIN FOR THE PAST WEEK AND A HALF. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED. ADDITIONAL INFORMATION NOTED THAT THE PROBLEM OF THE RECHARGER WAS NOT CHARGING HAD HAPPENED ¿ABOUT 2 WEEKS PRIOR TO THE CALL¿. THE PATIENT STATED THAT THEY HAD TRIED TO FIX THE RECHARGER THEMSELVES BUT WAS UNSUCCESSFUL. THERE WAS NO PATIENT INJURY REPORTED IN THE EVENT. THE INDICATION FOR USE INCLUDED FAILED BACK SURGERY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193726 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR