BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3182959 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10728
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 31, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 377745, LOT # V009839, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT # V009839, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37713, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND SHOWED A REDUCED CAPACITY DUE TO OVERDISCHARGE. IT WAS NOTED THAT THE BATTERY HAD DISCHARGED BELOW THE TEST LOWER LIMIT. THE DEVICE WAS RECEIVED WITH NO TELEMETRY RECOVERED WITH A PHYSICIAN MODE RECHARGE (PMR) PROCEDURE AND GOOD STABLE OUTPUT WAS SEEN ON ELECTRODE PAIRS THE INS HAD WHEN RECEIVED. THE TOTAL RECHARGE COUNT WAS REPORTED AS (B)(4). THE LAST RECHARGE SESSION WAS PERFORMED, WHILE THE DEVICE WAS IMPLANTED, ON (B)(6) 2007 (DEVICE WAS RECHARGED FOR 4 HOURS AND 48 MINUTES ¿ BATTERY CHARGED FROM 2.865 VOLTS TO 3.835 VOLTS). THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWED PATIENT USAGE AFTER THIS RECHARGE SESSION. IT WAS NOTED THAT THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2007. IT WAS ALSO REPORTED THAT THE BATTERY DISCHARGED RAPIDLY. ANALYSIS OF EXTENSION MODEL 3093-28, SERIAL #(B)(4) SHOWED NO SIGNIFICANT ANOMALIES WITH ACCEPTABLE CONTINUITY AND NO SHORTS SEEN BETWEEN CIRCUITS. ANALYSIS OF EXTENSION MODEL 3093-28, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES WITH ACCEPTABLE CONTINUITY AND NO SHORTS SEEN BETWEEN CIRCUITS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN OVERDISCHARGE WAS CONFIRMED, A PHYSICIAN MODE RECHARGE WAS NOT PERFORMED, AND THE DEVICE SYSTEM WAS EXPLANTED. IT WAS NOTED THAT THE DEVICE WAS NOT HELPING WITH THE PATIENT¿S PAIN AND SHE STOPPED USING IT AND RECHARGING IT OVER A YEAR AGO. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT AND THE PATIENT STATUS WAS NOTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST THERAPEUTIC EFFECT AND THE DEVICE WAS DEAD. IT WAS NOTED THE DEVICE WORKED UNTIL ¿LATE 2009.¿ THE REPORTER STATED THE DEVICE WASN¿T COVERING THEIR PAIN AND THEY HAD ACUTE PAIN. IT WAS NOTED THE PATIENT HAD TRIED TO CHARGE BUT ¿IT WOULDN¿T MAKE A CONNECTION TO CHARGE.¿ IT WAS FURTHER NOTED THE PATIENT HAD NOT CHARGED IN A FEW MONTHS AND COULD NOT REMEMBER EXACTLY. IT WAS NOTED THE PATIENT HAD LOST A LOT OF WEIGHT AND HAD BARIATRIC SURGERY. IT WAS FURTHER NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿STICKING OUT¿ OF THE SKIN. THE REPORTER STATED THEY CURRENTLY FUNCTIONED WITH MEDICINE. IT WAS NOTED THE PATIENT WANTED TO HAVE EVERYTHING REMOVED. IT WAS FURTHER NOTED THERE WERE NO KNOWN ACCIDENTS OR RELATED INCIDENTS. IT WAS FURTHER NOTED THE PATIENT WAS UNAWARE THE DEVICE COULD BE REPROGRAMMED AND HAD NOT SEEN THEIR HEALTH CARE PROFESSIONAL SINCE THEIR FOLLOW UP FROM SURGERY. THE REPORTER STATED THEY HAD NEVER CHARGED THEIR DEVICE. IT WAS UNCLEAR IF THIS REFERRED TO THE INS OR THE RECHARGER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282975 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 00049 YR Required Intervention