BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3023479 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04300
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 12, 2013
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6)2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT THE PATIENT WAS EXPERIENCING COUPLING AND COMMUNICATION ISSUES. IT WAS STATED THAT AN OVERDISCHARGE WAS SUSPECTED. REPORTEDLY THE PATIENT HAD BEEN "IN AND OUT OF THE HOSPITAL ABOUT A DOZEN TIMES", AND WHEN ASKED IF THESE VISITS WERE RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS), THE CALLER SAID "YES AND NO". IT WAS NOTED THAT THE CALLER TRIED THE ANTENNA LOCATE FEATURE UNSUCCESSFULLY. NO ADDITIONAL INFORMATION WAS KNOWN AT THE TIME OF REPORT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP).

    Description of Event or Problem · 1

    CALLER STATES THAT PT HAS BEEN IN AND OUT OF THE HOSPITAL ABOUT A DOZEN TIMES, AND WHEN PSS ASKED IF THESE VISITS WERE RELATED TO HIS INS, THE CALLER SAID "YES AND NO" AND THEN TRAILED OFF INTO MANY DETAILS ABOUT THE RECHARGER. IT WAS NOTED THE PATIENT HAD NEVER USED THE RECHARGE BELT. CALLER "DIDN'T THINK" HE HAD EVER SUCCESSFULLY RECHARGED. CALLER REPORTS PATIENT CONFUSING COUPLING BARS WITH INS CHARGE LEVEL. IT WAS REPORTED THE PATIENT ¿SHOULD HAVE HAD SOMEBODY ELSE WORK WITH THEM MORE¿ IN SHOWING THEM HOW THE DEVICE WORKED AND THEY WERE NEVER SHOWN HOW TO PUT THE BELT ON. REVIEWED DIFFERENCE BETWEEN COUPLING EFFICIENCY ROW AND INS BATTERY CHARGE LEVEL ICON. CALLER REPORTS COUPLING AND OR COMMUNICATION ISSUES. IT WAS LOGGED THE PATIENT WAS GETTING NO COUPLING BOXES. IT WAS NOTED THE PATIENT HAD FELT STIMULATION BEFORE BUT AT THE TIME OF THE REPORT HE DID NOT FEEL ANY STIMULATION. AN INS OVERDISCHARGE IS SUSPECTED. RECOMMENDED USING ANTENNA LOCATE FEATURE. AL FEATURE PRODUCED A 56 READING. PSS IS NOT CONFIDENT THAT CALLER AND PT ARE PERFORMING RECHARGING CORRECTLY, AND RECOMMENDED THAT THEY VISIT THE HCP TO GET A SLOW CHARGE, AND TO GO OVER RECHARGING AGAIN WITH THE DOCTOR OR REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125507 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 Hospitalization