FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 2863874 · Received December 10, 2012

Report

Report Number: 3004209178-2012-11374
Event Type: Injury
Date Received: December 10, 2012
Report Date: November 9, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8578 LOT# N115792, IMPLANTED: 2008 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER WAS NOTIFIED THE MEDICATION USED TO REFILL THE PUMP SHOWED "GROWTH". THE HCP REPORTED GETTING A PHONE CALL FROM THE COMPOUNDING PHARMACY THAT IS USED BY THE HOSPITAL INFORMING THEM THAT THE BACLOFEN THAT WAS REFILLED IN THE PUMP ON (B)(6) 2012 SHOWED "GROWTH". THE HCP HAD NOT YET CONTACTED THE PHARMACY YET TO DETERMINE DETAILS AS TO WHAT TYPE OF "GROWTH" THEY WERE REFERRING TO. THE PATIENT STATUS WAS ALSO UNKNOWN TO THE REPORTER, HOWEVER, NO SYMPTOMS HAD BEEN REPORTED. THE HCP REPORTED THAT THE PHARMACY RECOMMENDED EXTRACTING THE DRUG, BUT THE HCP FELT THE ENTIRE SYSTEM SHOULD BE EXPLANTED. IT WAS REPORTED LATER THAT DAY THAT THE HCP PLANNED TO REMOVE THE ENTIRE PUMP SYSTEM THAT EVENING OF (B)(6) 2012. THE PATIENT OUTCOME WAS NOT PROVIDED. THE MEDICATION IN THE PUMP WAS BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	863740

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention