BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4847526 · Received June 16, 2015

    Report

    Report Number
    3004209178-2015-11658
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    April 1, 2014
    Report Date
    March 21, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-39, LOT# N230415, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 239330001, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 355031 LOT# N232679, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID 355028 LOT# N229823, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS NOT WORKING PROPERLY. THE PATIENT SAW THE REPOSITION ANTENNA SCREEN. A COMMUNICATION PROBLEM WAS REPORTED. THE PATIENT STATED SHE HAD BEEN SEEING THIS SCREEN SINCE (B)(6) 2014. THE PATIENT ALSO REPORTED SHE HAD LOST AND GAINED WEIGHT. THE PATIENT WAS REDIRECTED TO THE HEALTH CARE PROVIDER (HCP). THERE WERE NO SYMPTOMS REPORTED. THERE WAS NO OUTCOME REPORTED. LATER, ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A CONFIRMED OVERDISCHARGE. THIS WAS THE FIRST OVERDISCHARGE. A PHYSICIAN MODE RECHARGE (PMR) WAS NOT PERFORMED. A POWER ON RESET (POR) OCCURRED AND THE ERROR CODE THAT ACCOMPANIED THE POR WAS NOT SPECIFIED. IT WAS NOT SUCCESSFULLY CLEARED. ACTIONS REQUIRED AS A RESULT OF THE EVENT WAS A REPLACEMENT. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED; IT WAS NOT REQUIRED. IF THERE WAS A PRODUCT ISSUE, THE ISSUE WAS NOT RESOLVED. THEY DID THE 60 MINUTE CLOCK 6 TIMES BEFORE THE BATTERY WENT INTO NORMAL RECHARGE. THE BATTERY WOULD NOT HOLD A CHARGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY. INFORMATION REGARDING WHEN THE REPLACEMENT WAS SCHEDULED AND PATIENT OUTCOME HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE HAD NOT BEEN REPLACED YET. IT WAS NOT HOLDING A CHARGE, AND AFTER 7 HOURS OF THE 60 MINUTE JUMP START IT WENT INTO NORMAL RECHARGE MODE. THE PATIENT WOULD GET A FULL CHARGE BATTERY AND WITHIN 12 HOURS IT WAS DEAD. THE DEVICE MANUFACTURER'S REPRESENTATIVE (REP) LET THE HCP KNOW THE PATIENT NEEDED A BATTERY REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THE REPLACEMENT SURGERY HAD NOT YET OCCURRED. THE INS WOULD NOT COMMUNICATION WITH THE RECHARGER AND HAD POOR COMMUNICATION ON THE PATIENT PROGRAMMER. IT WAS UNKNOWN WHEN THE PATIENT LAST FELT STIMULATION. THIS WAS CONSIDERED A GRADUAL CHANGE. THE PATIENT SAID THAT FOR A LONG TIME THEY COULD NOT CHARGE AND WAS HAVING ISSUES WITH GETTING THE INS TO CHARGE. AFTER MEETING WITH THE MANUFACTURER REPRESENTATIVE, THE DEVICE WAS CHARGED TO 100% ON (B)(6) 2015, BUT THE NEXT DAY IT WAS EMPTY. THE PATIENT STATED THAT THEY WERE IN PAIN. THIS WAS NOT NEW PAIN. IT HAD GRADUALLY WORSENED. IT WAS UNKNOWN IF THIS WAS A POTENTIAL OVERDISCHARGE/ DISCHARGE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390051 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention