ITREL 3

Report

Report Number: 6000032-2013-00001
Event Type: Injury
Date Received: January 2, 2013
Report Date: December 7, 2012
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 7496-66, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE DEVICE WAS POWERED OFF. IT WAS NOTED THE THREE LIGHTS ON THE BACK OF THE PATIENT PROGRAMMER WERE BLINKING AND WOULD GO OFF AND THE SECOND LIGHT DOWN SHOWS THAT BATTERY FOR IMPLANT WAS LOW. PATIENT HEARD THREE BEEPS AND PATIENT PROGRAMMER WOULD NOT TURN IMPLANT ON. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED DURING THE SUMMER AND HE WAS TOLD HE MAY HAVE TWO YEARS OR LESS LEFT. PATIENT NOTED INS WAS OFF AND THEY THINK THEIR BATTERY HAD DIED AFTER ALMOST TEN YEARS. IT WAS NOTED WHEN THE PATIENT TURNED ON THE PATIENT PROGRAMMER IT ONLY SHOWED "THE SECOND LIGHT ON WHERE THE ARROW POINTED TO UNIT. PATIENT HAD IMPLANT "ON FOR THIRTY SECONDS AND OFF FOR FIFTEEN SECONDS WHICH GIVES THEIR NERVE A CHANCE TO RELAX AND THE STIMULATION WORKED FOR THEM." IT WAS ALSO NOTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE LAST TIME THE PATIENT FELT STIMULATION WAS TWO DAYS PRIOR. PATIENT DOES NOT HAVE STIMULATION ON ALL THE TIME. IT WAS NOTED THE PREVIOUS NIGHT THE PATIENT T FORGOT TO PUT STIMULATION ON AND THEN THEY REMEMBERED TO PUT IT ON." IT WAS NOTED THE PATIENT KNEW THE DEVICE HAD WORKED A FEW DAYS PRIOR. IT WAS NOTED THE PATIENT WAS AT A COURTHOUSE AND THE PATIENT ALSO WANTED TO KNOW IF THAT COULD HAVE AFFECTED THEIR IMPLANT. IT WAS NOTED THIS WAS A "WORKMAN COMP SO THE PATIENT WOULD NEED TO GET IN TOUCH WITH THEM AND HEALTH CARE PROVIDER (HCP) FOR REPLACEMENT." IT WAS REPORTED THE PATIENT HAD A RADIO FREQUENCY "BURN NERVE" PROCEDURE LAST WEEK. IT WAS NOTED THE PATIENT WAS A "MESS." THE SAME DAY IT WAS REPORTED THERE WAS A POWER ON RESET (POR) CONDITION. IT WAS NOTED THE DEVICE WAS NEAR END OF LIFE (EOL). IMPEDANCES WERE ATTEMPTED BUT THE INS BATTERY WAS TOO LOW. A COUPLE DAYS LATER IT WAS REPORTED IMPEDANCES WERE RAN AT HIGHER AMPLITUDES AND THEY STILL CAME UP WITH REPEATING VALUES ON SOME COMBOS. C0 1206 C1, C2, AND C3 WERE 755. O1, AND 02 WERE 1531 AND 03, WERE 1507. FOLLOW UP REPORTED THE DEVICE WAS PLANNED TO BE REPLACED ON(B)(6) 2012. THE HCP HAD DECIDED IF ANY OTHER PROBLEMS WERE DISCOVERED DURING THE REPLACEMENT, FOR EXAMPLE WITH EXTENSION OR WIRE, THAT THEY WOULD COME BACK TO THE OPERATING ROOM ANOTHER TIME TO ADDRESS THAT ISSUE. IT WAS NOTED THE HCP WILL ONLY CHANGE THE INS AT THIS TIME. THERE WERE NO OTHER PROBLEMS STATED OR FOUND AT THIS TIME. FURTHER FOLLOW UP REPORTED THE PATIENT'S DEVICE WAS REPLACED AND THERE WERE NO FURTHER COMPLAINTS OR CONCERNS STATED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS UNAWARE IF PROBLEMS WERE FOUND WITH THE DEVICE. THE REPORTER STATED THAT IT WAS BELIEVED TO BE REGULAR DEVICE END-OF-SERVICE. THE DEVICE WAS REPLACED AND THE PATIENT WAS GETTING EFFE CTIVE STIMULATION. IT WAS REPORTED THAT THERE WERE NO FURTHER CONCERNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1976	ITREL 3	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MDT SOFAMOR DANEK PUERTO RICO MFG	7425

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention