SYNCHROMED II

MDR report key: 2853273 · Received November 30, 2012

Report

Report Number: 3004209178-2012-11002
Event Type: Malfunction
Date Received: November 30, 2012
Date of Event: October 30, 2012
Report Date: November 1, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 8709SC, LOT# B0941335K, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY. IT WAS INDICATED WHEN THE PATIENT WAS SEEN AT THE HOSPITAL FOR HIS SCHEDULED REFILL, IT WAS STATED THAT HIS PROBLEM STARTED ONCE HE BEGAN WEARING A 'NAN BIONIC VEST (FIR-TEX THE LABEL).' THE PUMP WAS INTERROGATED AND THERE WAS NO MESSAGES REPORTED. THERE WAS NO VOLUME DISCREPANCY NOTED WHEN THE PHYSICIAN EMPTIED THE PUMP. THE CATHETER WAS X-RAYED AND THERE WERE NO PROBLEMS FOUND. IT WAS NOTED THAT THE CATHETER'S CONDITION WAS CHECKED AND IT WAS FINE. HOWEVER, WHEN THE PHYSICIAN TRIED TO ASPIRATE FROM THE CATHETER ACCESS PORT, THERE WAS NO EFFECT. THE PHYSICIAN THEN REDUCED THE CONCENTRATION FROM 2000UG/ML TO 500UG/ML. IT WAS INDICATED THAT HE ALSO WANTED TO REDUCE THE DOSE TO MINIMUM RATE BEFORE PROCEEDING TO FURTHER TROUBLE-SHOOTING. THERE WAS NO PATIENT HARM OR INJURY. IT WAS INDICATED IN THE NEXT WEEKS THAT THE PHYSICIAN PLANS TO PERFORM A PUMP ROLLER TEST AND CATHETER CONTRAST. IT WAS REPORTED THAT THE PATIENT WAS FINE. THE DRUG DELIVERED VIA PUMP WAS LIORESAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1