BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4093309 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17109
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 21, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N281023, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3587A, LOT# LA6913, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-09, LOT# L88323, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. THE PATIENT COMPLAINED THEY HAD TO RECHARGE DAILY AFTER THE OVERDISCHARGE. THE CALLER STATED THE PATIENT WAS PULLED OUT OF OVERDISCHARGE 30 DAYS PRIOR TO (B)(6) 2014 BY ANOTHER MANUFACTURER REPRESENTATIVE. THE PATIENT HAD BEEN KEEPING THE IMPLANTABLE NEUROSTIMULATOR (INS) CHARGED OVER THE PAST 30 DAYS PRIOR TO (B)(6) 2014, BUT HAD FOUND THE RECHARGING OF THE INS TO BE ERRATIC. THE PATIENT CAME IN WITH THE INS CHARGED AND IT DEPLETED WITHIN A ¿MATTER OF HOURS.¿ THE PATIENT COULD CHARGE FROM ZERO TO ¾ FULL IN 10 TO 15 MINUTES. THE MANUFACTURER REPRESENTATIVE LEARNED ABOUT THE ¿RECHARGE ODDITIES¿ ON (B)(6) 2014. THIS WAS DESCRIBED AS QUICK DEPLETION, ¿LOTS¿ OF RECHARGING VERSUS HOW IT WAS BEFORE ETCETERA. THE PATIENT WOULD CONTINUE TO USE THE SYSTEM FOR A FEW WEEKS TO SEE IF IT IMPROVED. IT WAS NOTED THAT IF THERE WAS NO IMPROVEMENT THE PHYSICIAN MAY CONSIDER A PRIMARY CELL INS. IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING ISSUES CHARGING AND THE INS WOULD NOT HOLD A CHARGE ABOUT ONE MONTH PRIOR TO (B)(6) 2014. HOWEVER, THE CALLER NOTED THAT THIS WAS A GUESS AND THEY DID NOT HAVE A SPECIFIC TIMEFRAME. THE PATIENT WAS CHARGING AT THE DOCTOR¿S OFFICE AND THE HEALTHCARE PROFESSIONAL (HCP) NOTICED THE BATTERY WAS DEPLETING WHILE SITTING AT THE OFFICE. IT WAS UNKNOWN IF OTHER TROUBLESHOOTING WAS DONE OR IF THE PATIENT WAS IN OVERDISCHARGE. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT (B)(6) 2014. LATER, IT WAS REPORTED THAT THE INS WAS NOT REPLACED, BUT IT WAS RESCHEDULED FOR THE (B)(6). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT铠REPLACEMENT WAS CANCELLED AND DID NOT HAPPEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT铠CASE WAS CANCELLED AND NOT RESCHEDULED AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570876 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 00049 YR Required Intervention