BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3083364 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07031
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 19, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3550-39, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3550-39, PRODUCT TYPE: ACCESSORY. (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

    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 EXPERIENCED INCREASED PAIN. THE PATIENT SCHEDULED AN APPOINTMENT TO MEET WITH A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS UNABLE TO INTERROGATE THE BATTERY WITH AN 8840 OR THE PATIENT PROGRAMMER. THE PATIENT DID NOT BRING HER RECHARGER, BUT REPORTED HAVING CHARGED THE SYSTEM THE PREVIOUS NIGHT TO 3/4 CAPACITY. THE BATTERY WAS LYING STRANGELY IN THE PATIENT'S SKIN, ALMOST AS IF IT WERE SIDEWAYS. THE PATIENT WAS GOING TO TRY AND CHARGE AGAIN AND CALL THE MANUFACTURER REPRESENTATIVE WITH THE RESULTS. THE PATIENT ALSO REPORTED PAIN AROUND THE BATTERY SITE AND THAT CERTAIN MOVEMENTS CAUSING A "SHARP PAIN UP TO HER MID-BACK." IT WAS LATER REPORTED THAT THE PATIENT WAS NOT ABLE TO RECHARGE. SHE WANTED THE GENERATOR REPLACED, BUT HAD NOT RECEIVED AN APPOINTMENT DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT CHARGED IN QUITE SOME TIME, HAD NOT USED IT, AND WANTED IT ALL EXPLANTED. IT WAS NOTED THAT IT WOULD TAKE PLACE ON (B)(6) 2014. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR, LEAD, AND EXTENSIONS WERE EXPLANTED ON (B)(6) 2014. THE REPORTER NOTED THAT THE PATIENT HAD LOST WEIGHT AND THAT THE BATTERY WAS UNCOMFORTABLE AND BOTHERED HER. THE PATIENT RECOVERED WITHOUT SEQUELA AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185551 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention