FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 1178933 · Received September 26, 2008

Report

Report Number
2182207-2008-06153
Event Type
Injury
Date Received
September 26, 2008
Date of Event
July 1, 2008
Report Date
September 5, 2008
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
LKK
PMA / PMN Number
P860004
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GA, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT WAS STARTED ON A "LOW DOSE" (BELIEVED TO BE APPROX 1 MCG/DAY) AND INCREASED SLOWLY ON A WEEKLY BASIS TO APPROX 4.9 MCG/DAY IN ABOUT 5-6 WEEKS. WITH THE EXCEPTION OF THE SECOND DAY OF THE THERAPY WHEN THE PT HAD NO PAIN AT ALL, THE PT EXPERIENCED "VERY LITTLE PAIN RELIEF". IT WAS ALSO REPORTED THAT TWO DAYS AFTER STARTING PRIALT AND EACH TIME THE DOSE WAS INCREASED THE PT EXPERIENCED AN INCREASE IN BLOOD PRESSURE. THE PT'S BLOOD PRESSURE WAS USUALLY ABOUT 115-120/80-90. THE READINGS PROVIDED WERE 142/92 (2008), 174/108 (THE FOLLOWING DAY), AND 142/91 (SIX DAYS LATER). THE INCREASE IN BLOOD PRESSURE FOLLOWING DOSE INCREASE WAS TEMPORARY AND RESOLVED IN 2-3 DAYS. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED A DIFFICULTY WITH URINATION. THE PT HAD PRE-EXISTING DIFFICULTY WITH URINATION, BUT IT WORSENED AFTER PRIALT WAS INITIATED. THE SYMPTOMS IMPROVED SOMEWHAT, BUT THEN RECURRED AND WERE SO SEVERE THE PT WAS UNABLE TO VOID AND REQUIRED SELF-CATHETERIZATION (THE FOLLOWING MONTH). APPROX THREE WEEKS AFTER PRIALT THERAPY WAS INITIATED THE PT EXPERIENCED A "BURNING SENSATION ALL OVER". THE PT ALSO NOTED WEAKNESS IN HIS KNEES, DIFFICULTY WALKING, AND DIFFICULTY THINKING. AS OF THE DATE OF THIS REPORT, THE PT CONTINUED TO EXPERIENCE ALL OF THE SYMPTOMS, THOUGH IT WAS NOTED THAT THE "BURNING SENSATION" WAS "NOT AS BAD" AS IT HAD BEEN INITIALLY. IT WAS ALSO NOTED THAT PRIOR TO PRIALT THERAPY, THE PT RECEIVED BOTH IT MORPHINE AND DILAUDID. IT WAS REPORTED THAT THE PT DID NOT RESPOND TO THAT THERAPY. THE PT CONTINUED TAKING CONCOMITANT MEDICATIONS OF ORAL BACLOFEN AND METHADONE, AND A FENTANYL PATCH DURING THE ENTIRE COURSE OF PRIALT THERAPY. ADD'L INFO 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
1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention EXPLANTED:| PROGRAMMER MODE 8840| IMPLANTED:| CATHETER MODEL 8709