SYNCHROMED II

MDR report key: 1885004 · Received October 20, 2010

Report

Report Number: 3004209178-2010-08165
Event Type: Malfunction
Date Received: October 20, 2010
Date of Event: September 1, 2010
Report Date: September 22, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LKK
PMA / PMN Number: P860004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED A FLIPPED PUMP WAS CONFIRMED. IT WAS NOTED IMAGING WAS PERFORMED. IT WAS LATER REPORTED COMPANY REP NOTED PHYSICIAN CORRECTED THE FLIPPED BATTERY. COMPANY REP COULD NOT REMEMBER THE CONCENTRATION OR DOSE, BUT NOTED EVERYTHING STAYED THE SAME. IT WAS STATED PHYSICIAN NOTICED PUMP WAS FLIPPED WHEN HE WAS UNABLE TO ACCESS RESERVOIR TO DO A REFILL. PHYSICIAN REFILLED THE DRUG WITH THE SAME CONCENTRATION AS WAS PREVIOUSLY IN THE PUMP. COMPANY REP NOTED IT WAS LIORESAL IN THE PUMP. THERE WERE NO CHANGES TO DAILY DOSE MADE. IT WAS FURTHER NOTED THAT LIORESAL WAS USED IN THE PUMP DURING IMPLANT; HOWEVER, THE MANAGING CENTER USES COMPOUNDED BACLOFEN. THEY ARE A PAIN CENTER AND ONLY HAVE THIS ONE BACLOFEN PUMP. IT WAS BELIEVED THAT PT WAS REFILLED ONCE. PT HAD A CONCENTRATION OF 2000 MCG/ML AT A DOSE OF 414 MCG/DAY. COMPANY REP WAS UNSURE OF PT SYMPTOMS OR IF THEY HAD DIFFICULTY WITH REFILL, SO ASSUMED THE PUMP WAS FLIPPED. THE PT OUTCOME WAS UNK. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MDT PUERTO RICO OPERATIONS CO., JUNCOS	8637-40	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR			IMPLANTED:\| EXPLANTED:\| CATHETER: MODEL 8711, LOT# J11459R28