BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4337705 · Received December 17, 2014

    Report

    Report Number
    3004209178-2014-24148
    Event Type
    Injury
    Date Received
    December 17, 2014
    Report Date
    October 12, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED THE FOLLOWING (B)(4) ARE NOT RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) FOR A CLINICAL STUDY REPORTED THE PATIENT REPORTED HIS NEUROSTIMULATOR BATTERY WOULD NOT CHARGE AND HIS BATTERY WAS DISCHARGED ON (B)(6) 2014. THE DEVICE WAS INTERROGATED ON (B)(6) 2014, AND THE DEVICE DIAGNOSIS WAS THE NEUROSTIMULATOR WAS UNABLE TO RECHARGE. THE PATIENT RESOLVED WITHOUT SEQUELAE FOLLOWING DEVICE REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS RESOLVED WITH SEQUELAE. THE SEQUELAE WAS NOTED AS "AFTER REVISION THE PATIENT HAD BETTER COVERAGE, HOWEVER, DUE TO SCARRING THEY WERE NOT ABLE TO ACHIEVE ADEQUATE COVERAGE."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE IMPLANT DONE ¿PROBABLY 12 DAYS AGO.¿ IT WAS A BRAND NEW IMPLANT. THE PATIENT¿S BATTERY DIED WITHIN 24-48 HOURS OF HIM UTILIZING IT AFTER HE CHARGED IT. THE BATTERY DIDN¿T KEEP A CHARGE AND THE PATIENT WAS RECHARGING MORE OFTEN THAN EXPECTED. THE MANUFACTURER REPRESENTATIVE (REP) WAS UNSURE IF IT WAS BECAUSE OF HOW STRONG HIS AMPLITUDE WAS OR THE PATIENT¿S PARAMETERS OR WHAT. THE DEVICE WAS CHARGED COMPLETELY TO 100% AND IT DIED WITHIN 24 HOURS. IT WAS DEAD BY TUESDAY. THE REP SAW THE PATIENT LAST WEEK, (B)(6), TO ASSESS PATIENT'S RECHARGE INTERVAL. ¿EVERYTHING CHECKED ON THE IMPEDANCE CHECK.¿ IMPEDANCES WERE ALL ¿RELATIVELY LOW¿ LIKE 820, 840, 807 AND A COUPLE LIKE 1557 OHMS. THE PATIENT LOWERED HIS PARAMETERS. HE DECREASED HIS PULSE WIDTH TO 400US AND HIS RATE TO 60HZ, AND THE BEST HE COULD GET WAS THE BATTERY LASTING 48 HOURS BEFORE IT WENT COMPLETELY DEAD. THE PATIENT STILL HAD TO CHARGE EVERY 48 HOURS. THEY HAD TROUBLE CHARGING AND THE REP STATED IT COULD BE BECAUSE IT¿S STILL NEW AND THERE COULD BE SOME FLUID IN THE POCKET. THE PATIENT HAD COUPLING AND OR COMMUNICATION ISSUES. THE RECHARGER APPEARED TO BE WORKING FINE. THE REP WAS UNABLE TO INTERROGATE THE INS BECAUSE IT WAS DEAD. THE PATIENT WAS CHARGING WITH ALL 8 COUPLING BARS, BUT IT DEPENDED, SOMETIMES IT WOULD FALL DOWN TO 3-4, AND GO TO ZERO. IT WAS LATER REPORTED THE RECHARGING FREQUENCY AND INTERVAL MATCHED THE PATIENT¿S SETTINGS, AND THE PATIENT WAS ABLE TO DEMONSTRATE EFFECTIVE RECHARGING. IT WAS ALSO STATED THERE WERE NO MALFUNCTIONS SEEN. IT WAS NOTED THE STIMULATION WAS SET TO CYCLE ON AND OFF AND THE PATIENT USED ¿HIGH AMPLITUDES PULSE WIDTH OF 450US. REPORTEDLY, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND THE RECHARGE INTERVAL STRETCHED TO THREE OR FOUR DAYS INSTEAD OF 24-36 HOURS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN APPOINTMENT AT THE PAIN CENTER THE DAY OF THIS REPORT. THE PATIENT WANTED A MANUFACTURER REPRESENTATIVE (REP) TO MEET HIM AND SHOW HIM HOW TO USE THE PATIENT PROGRAMMER (PP). THE PATIENT HAD ISSUE WITH RECHARGING HIS PREVIOUS INS AND HAD NOT USED IT IN OVER A YEAR. A PRIMARY CELL INS WAS IMPLANTED DUE TO THE TROUBLES THE PATIENT HAD CHARGING THE OLD UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828753 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention