FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3790663 · Received May 5, 2014

Report

Report Number: 3004209178-2014-08523
Event Type: Injury
Date Received: May 5, 2014
Report Date: April 10, 2014
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: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE CATHETER REVEALED SIGNIFICANT TWISTING IN THE CATHETER BODY THAT MAY HAVE AFFECTED INFUSION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THEY HAD A VOLUME DISCREPANCY WHEREIN THE EXPECTED VOLUME (IN ML) WAS 14 AND THEY ASPIRATED (IN ML) 35.5. THEY HAD SUSPECTED A FLIPPED PUMP BUT HAD NOT CONFIRMED IT INITIALLY BUT LATER THE REPORTER INDICATED THAT THE PUMP WAS FLIPPING ACCORDING TO REPORT FROM CLINIC. A REVISION WAS DONE ON THE DATE OF THIS REPORT. WHEN PUMP SITE WAS OPENED THE CATHETER WAS FOUND TO BE TWISTED, KINKED AT THE PUMP CONNECTOR. THEY USED A CAP (CATHETER ACCESS PORT) KIT TO ASPIRATE BUT DIDN'T WORK. THE PHYSICIAN THEN UNTWISTED THE CATHETER AND WAS ABLE TO ASPIRATE 3ML EASILY. HE THEN REMOVED THE TWISTED PUMP SEGMENT, AND REPLACED IT WITH A NEW SECTION. HE ANCHORED THE PUMP AND RE-ASPIRATED TO ENSURE GOOD BACK FLOW. PATIENT STATUS AT TIME OF THIS REPORT ¿ALIVE - NO INJURY¿. PATIENT SYMPTOMS WERE REPORTED AS PAIN ALONG THE CATHETER TRACK. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
268555	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00052 YR		Required Intervention