BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4277571 · Received November 25, 2014

    Report

    Report Number
    3004209178-2014-22192
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    November 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V994388, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# VA0ELUV, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# VA00VYF, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (L/N VA00VYF), FOUND NO SIGNIFICANT ANOMALY. THE DISTAL END OF THE CONDUCTOR WAS BROKEN (OVERSTRESS/DAMAGE).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (S/N (B)(4)), FOUND NO SIGNIFICANT ANOMALY. THE INS WAS FUNCTIONALLY OKAY. ANALYSIS OF THE LEAD (L/N V994388), FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY WAS CUT THROUGH AND THE PRODUCT SEGMENTED. ANALYSIS OF THE LEAD (L/N VA0ELUV), FOUND NO SIGNIFICANT ANOMALY. THE DISTAL END OF THE LEAD WAS STRETCHED. THE FOLLOWING METHOD CODE IS ALSO APPLICABLE TO THIS EVENT. THE FOLLOWING RESULT CODE IS NO LONGER APPLICABLE TO THIS EVENT. THE FOLLOWING CONCLUSION CODE IS NO LONGER APPLICABLE TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE THERAPY WAS NOT CONTROLLING THE PAIN. THERE WAS LUMBAR DISCOGENIC PAIN AND CHRONIC LOWER BACK PAIN. THE DEVICE WAS EXPLANTED, RETURNED TO THE MANUFACTURER, AND IT WAS NOT REPLACED. THERE WAS NO PATIENT DEATH OR INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LEAD WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS BELLY PAIN FROM THE THORACIC SITE AND WITHOUT ANY EFFICACY. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DECIDED TO HAVE THE STIM REMOVED. THE PATIENT HAD PAIN AT THE LAMINECTOMY SITE EVEN WITH THE STIM OFF. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP WAS REQUESTED. IF RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PER THE PATIENT, THE STIMULATOR WAS NOT GOING TO WORK FOR HER. THE LITTLE RELIEF THE PATIENT RECEIVED FROM THE ELECTRICITY WAS NOT WORTH ALL OF THE OTHER PAIN. THE MANUFACTURER REPRESENTATIVE MET THE PATIENT (B)(6) 2014 FOR A STANDARD POST-OPERATIVE VISIT WITH THE DOCTOR. THE PATIENT WANTED THE STIM OUT BECAUSE IT WAS ¿CAUSING MORE PAIN.¿ IN ASSESSING THE PATIENT¿S COMPLAINT, SHE COMPLAINED OF PAIN BETWEEN HER SHOULDER BLADES. THIS WAS FROM A LAMINECTOMY WITH THE SURGICAL PADDLE LEAD PLACEMENT. THIS WAS NOT SOMETHING THE STIM WOULD HELP AND REMOVING THE STIM WOULD NOT HELP EITHER. THIS WAS POST-OPERATIVE PAIN TO BE EXPECTED FROM WHAT THE MANUFACTURER REPRESENTATIVE COULD GATHER OVER THE PHONE. IN ADDITION, THE PATIENT STATED HER SPINE WAS FOUND TO BE ¿TOO SMALL¿ AND THE LEADS WERE AGGRAVATING HER ARTHRITIS EVEN MORE. THE PATIENT STATED IT WAS UNFORTUNATE, BUT IT WOULD BE HER DECISION TO HAVE IT REMOVED. THE PATIENT STATED THE DOCTOR DID HIS BEST, BUT SHE DID NOT FEEL SHE WAS A GOOD CANDIDATE FOR THE IMPLANT. LATER, THE PATIENT REPORTED THAT THE DEVICE WAS PROGRAMMED A COUPLE OF TIMES BUT WOULD TRY AGAIN, ¿JUST SO SHE COULD COVER ALL BASES FOR HER DOCTOR.¿ HOWEVER, THE PATIENT STATED THAT SHE WAS UNABLE TO TRAVEL STATING, ¿THE CAR RIDE BUMPS THE LEADS AND I WOULD BE IN AGONY. I HAD NO IDEA THIS WOULD BE SUCH A BIG PRODUCTION.¿ THE PATIENT FURTHER STATED, ¿IT MIGHT AS WELL HAVE BEEN A FUSION AS THE ¿RECOVERY TIME¿ IS HIDEOUS.¿ THE PATIENT WOULD NOT GO THREE OR FOUR MONTHS WITH THIS, ¿THINKING IT WOULD CALM DOWN.¿ THE PATIENT ALREADY HAD ¿ENOUGH PAIN FOR THREE LIFETIMES.¿ THE MANUFACTURER REPRESENTATIVE SUSPECTED THE ¿THINKING IT WOULD CALM DOWN¿ WAS IN REFERENCE TO WHAT THE DOCTOR TOLD HER DURING THE FIRST POST-OPERATIVE APPOINTMENT. THE PAIN FROM LAMINECTOMIES USUALLY DOES CALM DOWN OVER TIME. THE PATIENT¿S NEXT APPOINTMENT WITH THE DOCTOR WAS (B)(6) 2014. THE MANUFACTURER REPRESENTATIVE WOULD BE PRESENT AND COULD RELAY THE DOCTOR¿S OPINION FOLLOWING THE APPOINTMENT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR THIS INFORMATION. IF RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764560 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention