SYNCHROMED II

Report

Report Number: 3004209178-2013-07313
Event Type: Malfunction
Date Received: May 4, 2013
Report Date: April 4, 2013
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: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: UNK. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS LATER REPORTED THAT THE CATHETER WAS COILED AT T11 AND T12 WITH MULTIPLE LOOPS. IT WAS UNKNOWN IF THE COILING WAS INTENTIONAL. THE PUMP WOULD NEED TO BE REPLACED NEXT YEAR, AND THE HEALTHCARE PROVIDER (HCP) WAS NOT GOING TO ADDRESS THE COILING.

Description of Event or Problem · 1

IT WAS REPORTED THE "CATHETER IS COILED." LAST YEAR (2012) PATIENT WAS TOLD BY THE HCP THE CATHETER WAS COILED. IT WAS CONFIRMED BY A CT SCAN AND WAS "COILED IN MULTIPLE PLACES." THE HCP SENT HER TO THE HOSPITAL WHERE MRI'S AND "STUFF" WERE DONE AND THEY SAID IT WAS NOT WASN'T CAUSING ANY PROBLEMS. PATIENT'S SPASTICITY WAS GETTING WORSE; "SPASTICITY IS WORSE THAN IT EVER HAS BEEN." THE PATIENT ALSO WAS EXPERIENCING PAIN IN HER BACK AND WAS PLANNING ON SEEING A CHIROPRACTOR. THE PATIENT WAS ALSO SEEKING A CLOSER HCP. THE PUMP WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT PATIENT HAD EXPERIENCED CONSTIPATION AND WAS REFERRED TO A NEUROSURGEON. THERE WAS A CATHETER LOOP AT THE DISTAL/SPINAL SEGMENT, THAT WAS "MOST LIKELY A FINDING AT IMPLANTATION DISCOVERED BY THE NEUROSURGEON DUE TO ONSET OF CONSTIPATION". IT WAS NOTED THAT PATIENT WAS HOSPITALIZED AND RECOVERED WITHOUT SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
195816	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	863720

Patients

Seq	Age	Sex	Outcome	Treatment
1	00027 YR		Hospitalization