FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3973742 · Received August 1, 2014

Report

Report Number: 3004209178-2014-13844
Event Type: Injury
Date Received: August 1, 2014
Report Date: July 12, 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: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALY.

Description of Event or Problem · 1

IT WAS REPORTED THE PUMP WAS EXPLANTED. THERE WERE VOLUME DISCREPANCIES WHERE THE ACTUAL VOLUMES WERE TWICE THAT OF EXPECTED. THE EXACT VOLUMES WERE NOT KNOWN. ON REPORTED VOLUME DISCREPANCY HAD THE EXPECTED VOLUME AS 2 MILLILITERS AND THE ACTUAL VOLUME AS 4 MILLILITERS. THE CATHETER WAS CHECKED FOR PATENCY AND IT WAS GOOD. THE SYSTEM WAS BEING USED TO DELIVER DILAUDID AND BUPIVACAINE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ IT WAS LATER REPORTED NO ROTOR STUDY OR DYE STUDY WERE PERFORMED. IT WAS ALSO REPORTED THERE WERE NO SYMPTOMS RELATED TO THE EVENT AND NO CAUSE FOR THE DISCREPANCY DETERMINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451285	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention