BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2913429 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00515
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8591-38 LOT# D29219, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INS SYSTEM WAS EXPLANTED DUE TO INFECTION. IT WAS NOTED THAT THE CUSTOMER DISCARDED THE EXPLANTED DEVICES. IT WAS NOTED THAT THERE WERE NO SYMPTOMS ASSOCIATED WITH THE EVENT AND THAT THE PATIENT OUTCOME WAS REPORTED AS "ALIVE NO INJURY/ADVERSE EVENT".

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT DEVELOPED A SEVERE INFECTION ABOUT ONE MONTH AGO. IT WAS STATED, THE INFECTION "WENT FROM THE UNIT UP TO THE ELECTRODES" ON THE SPINE. ANTIBIOTICS WERE PRESCRIBED, ALONG WITH PAIN MEDICATION. IT WAS INDICATED, THE ANTIBIOTICS "WORKED FASTER THAN EXPECTED." LATER, THE PATIENT DEVELOPED PAIN IN BOTH FLANKS UP TO THEIR SPINE AND TO THE BOTTOM OF THEIR RIB CAGE. IT WAS STATED THAT NO PAIN MEDICINE HELPED TO RELIEVE THE PAIN. AN ULTRASOUND TAKEN CAME BACK NEGATIVE FOR KIDNEY OR GALL STONES. IT WAS INDICATED, THE PAIN "GOT MUCH WORSE" AND THE PATIENT HAD TO GO TO THE EMERGENCY ROOM (ER). A BLOOD AND URINE TEST WERE ALSO COMPLETED, BUT FOUND "NOTHING WRONG." NO FURTHER ACTION WAS TAKEN AT THAT POINT. THE PATIENT RETURNED TO THE ER WITH "EXTREME PAIN" MOSTLY IN THE RIGHT FLANK AND "DOWN THEIR SPINE FROM THE CENTER DOWN." A C-SCAN WAS COMPLETED AND THE RESULTS WERE NEGATIVE. THE CAUSE OF THE PAIN WAS UNKNOWN. IT WAS NOTED, THE PAIN WAS WORSE WHEN THE DEVICE WAS ON, THEREFORE, THE PATIENT HAD NOT TURNED IT ON AGAIN. IT WAS FURTHER STATED THAT PATIENT COULD NOT "SLEEP, LAY ON THEIR BACK OR SIDES, AND HAD TO SLEEP IN A CHAIR." PAIN COULD BE FELT IN THEIR "KIDNEY AREAS." THE FOLLOWING DAY, IT WAS REPORTED, THE INITIAL INFECTION REDEVELOPED AFTER BEING CLEARED WITH ANTIBIOTICS. THE PHYSICIAN THEN RE-PRESCRIBED STRONGER ANTIBIOTICS ALONG WITH SOME PAIN MEDICATION. INTERROGATION WAS DONE ON THE DEVICE AND IT "CHECKED OUT FINE." IT WAS ALSO NOTED, WHEN STIMULATION WAS OFF, THE PAIN WAS "BETTER, BUT STILL THERE." A LITTLE MORE THAN A WEEK LATER, THE PATIENT WAS STILL HAVING PAIN. IT WAS STATED, THE WOUND/INCISION "LOOKED GREAT" AND THERE WAS NO SIGN OF INFECTION. THE PATIENT WAS PLACED AT PRN (PRO RE NATA) STATUS BY THE PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS DUE TO A 'POSSIBLE' SUBCLINICAL INFECTION AFTER ANTIBIOTICS. IT WAS STATED AN EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR WAS 'BEING CONSIDERED.' IT WAS INDICATED THAT REPROGRAMMING WAS COMPLETED IN (B)(6) 2012. NO HOSPITALIZATION WAS REPORTED. THE PATIENT OUTCOME WAS LISTED AS NO INJURY. IT WAS FURTHER NOTED THERE WAS INCREASED OPIATE USE AS WELL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21531 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 Required Intervention