BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2638981 · Received July 3, 2012

    Report

    Report Number
    3004209178-2012-05177
    Event Type
    Injury
    Date Received
    July 3, 2012
    Report Date
    June 5, 2012
    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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748966 LOT# SERIAL# (B)(4) IMPLANTED: 2009-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 74001 LOT# N317246 SERIAL# IMPLANTED: 2012-(B)(6) EXPLANTED: PRODUCT TYP ADAPTER PRODUCT ID 74001 LOT# N317246 SERIAL# IMPLANTED: 2012-(B)(6) EXPLANTED: PRODUCT TYP ADAPTER PRODUCT ID 3987A LOT# N121942 SERIAL# IMPLANTED: 2009-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 37744 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 74001, LOT# N317246 , IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ADAPTER, PRODCUT ID PLUG ACCESSORY, IMPLANTED: 209 (B)(6), EXPLANTED: 2012 (B)(6), PLUG ACCESSORY.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT UNDERWENT A SURGICAL REVISION ON (B)(6) 2012. IT WAS OBSERVED THAT THE INTRA-POCKET CONNECTION AND POSITIONING OF THE ADAPTOR AND THE EXTENSION PLUG APPEARED "SUB-STANDARD". THE EXTENSION AND POCKET ADAPTOR COMPONENTS WERE REMOVED AND REPLACED. IN ADDITION, THE INS BATTERY WAS REPLACED AT THE SAME TIME. POST-OP, THE PATIENT WAS REPORTED TO BE "DELIGHTED" WITH THE RESULTS WITH GREAT COVERAGE FOR THEIR PAIN AND THE EXTRANEOUS INFLUENCES ON THEIR STOMACH COMPLETELY GONE. THE PATIENT WAS "VERY HAPPY" TO HAVE THEIR COVERAGE BACK TO NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND VOMITING SINCE IMPLANTATION OF THEIR NEW IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE INS WAS TURNED OFF FOR 5 DAYS THE PATIENT DID NOT HAVE ANY STOMACH ISSUES. THE INS WAS REPROGRAMMED YESTERDAY TO ELECTRODES #2 & 3 AND GIVEN TWO PROGRAMS AND LEFT ON. THE PATIENT'S WIFE THEN STATED THAT AT 8 PM THAT SAME DAY THE PATIENT AGAIN EXPERIENCED THE NAUSEA AND VOMITING ISSUES AND WAS UP ALL NIGHT UNTIL 7 AM. THE INS WAS THEN TURNED OFF. IT WAS ALSO NOTED THAT THE PATIENT WAS SEEN BY A GASTROLOGIST IN THE EMERGENCY ROOM WHERE THEY WERE DIAGNOSED WITH A SPASTIC STOMACH. IN ADDITION, THE PATIENT WAS REPORTED TO HAVE HAD SPASMS OF THE STOMACH BEFORE WHICH WERE NOTED AS "NOT RELATED" TO THE DEVICE. THE PATIENT HAD AN APPOINTMENT NEXT MONTH TO VISIT A GASTROINTESTINAL (GI) SPECIALIST. IT WAS ALSO REPORTED THAT THE DEVICE, UP TO THE CURRENT EVENT, HAD BEEN A "LIFE SAVER FOR HIM" AND HIS FAMILY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2012. THE PATIENT WAS GOING TO HAVE AN OLD EXTENSION AND POCKET ADAPTOR REPLACED WITH A NEW EXTENSION, AND THE INS REPOSITIONED FROM THE LEFT ABDOMEN TO THE LEFT BACK OR FLANK. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention