BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3132281 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08256
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THAT THE BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. THE BATTERY REQUIRED RECHARGING WHEN RECEIVED; THE BATTERY CHARGED FOR 2 HOURS FROM 3.395V TO 3.905V. THE BATTERY OVER DISCHARGE COUNT IS 1. ACCORDING TO THE BATTERY RECHARGE DIAGNOSTIC IN THE TRACE REPORT OBTAINED FROM THE INS; THE TOTAL RECHARGE COUNT IS 36. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS (B)(6) 2000 (DEFAULT DATE PLUS TWO DAYS). THE DEVICE WAS RECHARGED FOR 1 HOUR 27 MINUTES AND THE BATTERY CHARGED FROM 3.565V TO 3.575 VOLTS. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2012; THE BATTERY HAS DISCHARGED TO THE LOCK MODE 4 TIMES SINCE THE LAST 8840 INTERROGATION. BATTERY WAS CHARGED AGAIN FOR ANALYSIS AT BODY TEMPERATURE WITH APPROXIMATELY 1CM OF SPACE BETWEEN THE INS AND CHARGER ANTENNA. THE BATTERY CHARGED FOR 3 HOURS AND 56 MINUTES FROM 3.560V TO 4.040V. ANALYSIS OF THE 3777 LEAD FOUND THAT WIRES 1, 2, 3, 5, AND 6 WERE BROKEN 22 CENTIMETERS FROM THE DISTAL END. ANALYSIS OF THE 3550-29 ACCESSORY PLUG-BOOT FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777, PRODUCT TYPE LEAD. (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 AN OVERDISCHARGE WAS CONFIRMED DUE TO PATIENT NON-COMPLIANCE. DURING THE PHYSICIAN MODE RECHARGE SESSION THE PHYSICIAN NOTICED A LUMP THAT HAD DEVELOPED OVER THE STIMULATOR SITE. THE PATIENT HAD NOTED THE LUMP HAD BECOME INCREASINGLY UNCOMFORTABLE OVER THE PAST FEW MONTHS. SEVERAL ATTEMPTS AT A PHYSICIAN MODE RECHARGE WERE ATTEMPTED BUT NO SUCCESSFUL. DUE TO UNSUCCESSFUL PHYSICIAN MODE RECHARGE AND THE LUMP OVER THE IMPLANT SITE THE PHYSICIAN DETERMINED IT WAS NECESSARY TO EXPLANT THE DEVICE. IT WAS NOTED THE PATIENT HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. SYMPTOMS INCLUDED BURNING SENSATION, PAIN AND SWELLING AT THE DEVICE POCKET. THE PATIENT¿S STATUS WAS NOTED AS ALIVE WITH INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237557 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 00052 YR Required Intervention