BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4111516 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17588
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 28, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97754, SERIAL (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37791, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#(B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37791, SERIAL# UNKNOWN , PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (S/N (B)(4)), FOUND NO ANOMALY. THE INS PASSED FUNCTIONAL TESTING INCLUDING HEAT TESTING DURING RECHARGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOT OF HEAT WHILE RECHARGING. THE PATIENT WOULD LIE ON THE ANTENNA TO CHARGE SINCE THE IMPLANTABLE NEUROSTIMULATOR (INS) HEALED AT AN ANGLE. THE PATIENT FELT THE ANTENNA GOT TOO HOT BUT NEVER ROSE TO THE TEMPERATURE WHEN RECHARGING WOULD STOP AND NEVER GOT ABOUT 99F. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS CONSIDERING REPLACING THE INS WITH A NON-RECHARGEABLE DEVICE. A LONGEVITY CALCULATION WAS PERFORMED AND DETERMINED THAT THE INS WOULD LAST FOR ABOUT 39 MONTHS. THE PATIENT WANTED TO CONTINUE TO GIVE THE RECHARGER A TRY. THE RECHARGER HEAD WAS REPLACED BUT NOTHING WAS IMPROVED BUT THE PATIENT WANTED TO CONTINUE TO TRY. ABOUT SIX MONTHS LATER, ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED YESTERDAY. THE PATIENT¿S STATUS AFTER SURGERY WAS RECOVERED WITHOUT SEQUELA AND WAS HAPPY AND RECEIVING EFFECTIVE THERAPY. THE PATIENT WAS IMPLANTED WITH A PRIMARY CELL BATTERY AND WAS GOING TO LET THE MANUFACTURER¿S REPRESENTATIVE (REP) KNOW WHEN SHE WAS READY TO HAVE IT REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591941 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention