SYNCHROMED II

MDR report key: 2894600 · Received January 3, 2013

Report

Report Number: 3004209178-2013-00082
Event Type: Malfunction
Date Received: January 3, 2013
Report Date: September 6, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD BEEN UP ALL NIGHT WITH HER "SPINE LOCKED." IT WAS UNCLEAR WHAT "SPINE LOCKED" IMPLIED, WHETHER IT WAS RELATED TO PAIN, RIGIDITY, OR ANOTHER SYMPTOM. HOWEVER, IT WAS NOTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH MULTIPLE SCLEROSIS ON (B)(6) AND ALSO MENTIONED THAT SHE HAD A "BAD SPINE DISEASE." DURING THE TRIAL, THE PATIENT WAS PAIN-FREE. WHEN HAVING HER PUMP INITIALLY FILLED WITH DRUG, SHE WAS REPORTEDLY GIVEN THREE TIMES THE CORRECT DOSAGE AND HAD TO WAIT SIX HOURS BEFORE THE CORRECT DOSAGE WAS PUT IN. THE DRUG BEING USED IN THIS SYSTEM WAS MORPHINE. FIVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT FELT SHE WAS NOT GETTING AS MUCH PAIN RELIEF AS SHE DID DURING HER TRIAL. IT WAS NOTED THAT THE PATIENT WAS GIVEN A SINGLE BOLUS DURING HER TRIAL, WHILE THE INFUSION WOULD BE SLOWLY INCREASED OVER THE NEXT SEVERAL WEEKS. THE PHYSICIAN STATED THAT DUE TO THIS, THE TREATMENT MAY NOT FEEL THE SAME. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS GOING TO VISIT HER PHYSICIAN FOR FOLLOW-UP AND TO "INCREASE HER PUMP AGAIN." ABOUT TWO MONTHS LATER, IT WAS REPORTED THAT THE PATIENT WAS "DOING WELL."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2753	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1