BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2892424 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00021
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 389033, LOT# V061767, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 355029, LOT# N0043992, IMPLANTED: (B)(6) 2005, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES. THE REPORTER STATED THAT AN OVERDISCHARGE WAS SUSPECTED, AND THE PATIENT HADN'T RECHARGED THE DEVICE SINCE IT WAS IMPLANTED. IT WAS UNKNOWN WHY THE PATIENT DIDN'T RECHARGE THE DEVICE. A WEEK LATER, IT WAS REPORTED THAT THERE WAS AN OVERDISCHARGE AND THE DEVICE HAD NOT BEEN RECHARGED IN 18 MONTHS. THE PATIENT WAS TAKEN THROUGH A PMR (PHYSICIAN MODE RECHARGE) AND THE PATIENT CONTINUED TO TRY FIVE MORE TIMES AFTER THAT TO TRY AND BRING THE BATTERY BACK. THE REPORTER STATED THAT AFTER THE SIXTH TIME THE PATIENT SAID SHE WAS DONE TRYING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT ALLEGED SHE NEVER RECEIVED A RECHARGER. THIS WAS STATED ON SEVERAL OCCASIONS. MULTIPLE RECHARGERS WERE NOTED TO HAVE BEEN GIVEN TO HER. THE PATIENT THEN FOUND HER RECHARGER. THE MANUFACTURER REPRESENTATIVE WAS GOING TO MEET WITH THE PATIENT ON (B)(6) 2015 AT A FOLLOW-UP MEETING WITH HER HEALTHCARE PROVIDER (HCP). FOLLOW-UP WAS PERFORMED TO DETERMINE IF A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED AND SUCCESSFUL AT THE APPOINTMENT, IF ADDITIONAL TROUBLESHOOTING HAD OCCURRED, AND IF THE PATIENT WAS ABLE TO CHARGE AND RECEIVED EFFECTIVE THERAPY. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAS A HISTORY OF NON-COMPLIANCE. THEY MET WITH THEIR MANUFACTURER REPRESENTATIVE ON (B)(6) 2015 AND THE BATTERY WAS DEPLETED. THEY HAD NOT CHARGED THE DEVICE SINCE 2011 AND A PHYSICIAN MODE RECHARGE (PMR) WAS UNSUCCESSFUL IN RECOVERING THE DEVICE. THE PATIENT OPTED TO HAVE THE DEVICE EXPLANTED HOWEVER NO DATE HAD YET BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864 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 00067 YR Required Intervention