BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3063490 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06436
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708140 LOT# SERIAL#(B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE STIMULATOR REVEALED THAT THE BATTERY WAS OVERDISCHARGED AND PERMANENTLY DAMAGED. THE THERAPY AVAIL DIAGNOSTIC SHOWED THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(4) 2012; THE BATTERY HAD DISCHARGED TO THE LOCK MODE 4 TIMES SINCE THE LAST 8840 INTERROGATION. THE CONDITION OF THE PORTS SHOWED NO SIGN OF SHORTING OR MALFUNCTION TO CAUSE DAMAGE TO A LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 SURGEON INTENDED TO SWAP FROM A RECHARGEABLE STIMULATOR TO A PRIMARY CELL, BUT COULD NOT GET THE LEADS TO FIT. THE SURGEON THOUGHT THAT THE BATTERY MAY HAVE SHORTED AND DAMAGED THE LEAD. THE PRODUCT WAS NOT REPLACED. THERE WERE NO INJURIES AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164676 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