BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3242498 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12146
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    January 1, 2012
    Report Date
    June 7, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 9565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ¿WAS TOLD HER IMPLANTABLE NEUROSTIMULATOR (INS) WOULD LAST FIVE YEARS¿ AND THAT IT ¿DIED AFTER TWO¿ YEARS. THE PATIENT DID NOT KNOW WHETHER THE INS DIED DUE TO NORMAL BATTERY DEPLETION. IT WAS STATED THE INS WORKED "GREAT" FOR THE PATIENT BEFORE IT DIED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD SLIPPED ON A PATCH OF BLACK ICE AND RUINED HER SPINE. IT WAS FURTHER NOTED THAT THE PATIENT STATED SHE SHOULD HAVE KNOWN SHE NEEDED MORE PAIN RELIEF FROM HER LUMBAR AREA. PATIENT NOTED THAT SHE HAD WASTED TIME AND MONEY ON THE SPINAL CORD STIMULATOR WHICH HAD ONLY DONE HALF THE JOB SHE NEEDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE BATTERY DEPLETION WAS CONSIDERED NORMAL. IT WAS NOTED THE PATIENT USED HIGHER AMPLITUDE AND MANY ELECTRODES FOR DESIRED THERAPEUTIC EFFECT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INS WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON MAY 11TH 2016 STATING THAT THEY NO LONGER HAD STIMULATORS. THE FIRST IMPLANTABLE NEUROSTIMULATOR (INS) DIED AFTER 2 YEARS, NOTING THAT THEY LEFT IT ON 24/7.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INS HAD "ONLY HELPED THE PAIN IN HER LUMBAR SPINE." IT WAS NOTED THAT THE PATIENT'S INS HAD NOT BEEN "AS GOOD AS HER PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343030 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention