FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 4844615 · Received June 15, 2015

Report

Report Number: 3004209178-2015-11600
Event Type: Injury
Date Received: June 15, 2015
Date of Event: May 22, 2014
Report Date: May 26, 2015
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: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 8711, LOT# N123159001, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT THERE WAS NO CHANGE IN PAIN CONTROL FROM THE PREVIOUS VISIT NOR WERE THERE ANY SIGNS OF WITHDRAWAL THAT LEAD TO THE DIAGNOSTICS BEING PERFORMED ON (B)(6) 2014.

Description of Event or Problem · 1

A CATHETER FRACTURE WAS REPORTED. DIAGNOSTICS METHODS INCLUDED INABILITY TO ASPIRATE FLUID, NO FREE FLOW OF CSF ON SIDEPORT TAP, (B)(4) 2014 AND ISOTOPE PUMP STUDY, NO DELIVERY OF DRUG TO THE INTRATHECAL SPACE, (B)(4) 2014 AND A CT SCAN WITHOUT CONTRAST, CATHETER FRACTURE ON (B)(4) 2014. INTERVENTION INCLUDED REPLACING THE CATHETER ON (B)(4) 2014. IT WAS NOTED TO BE RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE SEVERITY WAS INDICATED AS MILD AND THE OUTCOME RESOLVED WITHOUT SEQUELAE (B)(4) 2014. THE PUMP WAS USED TO DELIVER SUFENTANIL, CLONIDINE AND PRIALT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION LATER RECEIVED REPORTED NO SYMPTOMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
388688	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	863720

Patients

Seq	Age	Sex	Outcome	Treatment
1	00055 YR		Required Intervention