FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3366973 · Received September 25, 2013

Report

Report Number: 3004209178-2013-16884
Event Type: Injury
Date Received: September 25, 2013
Report Date: September 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: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 8575, LOT# N182457, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8590-1, LOT# N199219, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT MISSED HER SCHEDULED REFILL APPOINTMENT DUE TO BEING ADMITTED TO A NURSING HOME. THE PATIENT EXPERIENCED A CHANGE IN THERAPEUTIC EFFECT AND MIGHT HAVE HAD SOME WITHDRAWAL ISSUES. IT WAS INDICATED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL, BUT NOBODY RECOGNIZED WHAT WAS GOING ON. THE PATIENT THEN BECAME VERY ILL AND HAD A ¿SEIZURE ACTIVITY¿. IT WAS STATED THAT THE NURSING HOME EVENTUALLY RECOGNIZED THAT THE PATIENT HAD A PUMP, BUT BASED ON THE REPORTER¿S CALCULATIONS, THE PUMP HAD ALREADY BEEN EMPTY FOR TWO WEEKS. IT WAS REPORTED THAT, AT THE TIME OF REPORT, THE PATIENT WAS STABLE AND GETTING A REFILL, THOUGH THE HEALTHCARE PROVIDER CONSIDERED LOWING THE DOSE OF MORPHINE TO 1MG/DAY. IT WAS STATED THAT THE PATIENT HAD BEEN ON A VERY LIMITED NARCOTIC INCLUDING ORAL MEDICATIONS, THOUGH SHE DID HAVE PAIN. THE HCP WAS ALSO CONCERNED THAT THE PUMP WOULD NOT BE WORKING PROPERLY. THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE AND MORPHINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
485226	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00065 YR		Hospitalization