SYNCHROMED II

MDR report key: 1980384 · Received February 2, 2011

Report

Report Number: 3004209178-2011-00818
Event Type: Injury
Date Received: February 2, 2011
Date of Event: December 1, 2010
Report Date: January 27, 2011
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE PT WAS HOSPITALIZED 3 TIMES DUE TO PUMP PROGRAMMING/OVERDOSE ISSUES. THE PUMP CONTAINED FENTANYL 1600 MCG/ML, DILAUDID 52 MCG/ML, CLONIDINE 320 MCG/ML, AND PRIALT 10 MCG/ML. TWO HOURS AFTER A PUMP REFILL IN (B)(6) 2010, THE PT KNEW "SOMETHING WASN'T RIGHT." THE PT EXPERIENCED "TERRIBLE MUSCLE SPASMS" IN HER BACK AFTER THE PUMP DRUG PRIALT WAS INCREASED. THE PT WENT TO THE EMERGENCY ROOM. THE PT'S PHYSICIAN INDICATED THE DRUG WAS "TOXIC." THE PUMP WAS "DRAINED" AND REFILLED. THE PT WENT HOME THE FOLLOWING DAY. THE PT THEN COULD NOT WALK OR SPEAK. THE PT WAS "NOT CONSCIOUS" AND WAS NOT ABLE TO BE AROUSED. THE PT RETURNED TO THE HOSPITAL WITH SUSPECTED OVERDOSE. THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL. THE PT REMAINED HOSPITALIZED FOR 3.5 WEEKS. THE PUMP WAS "DRAINED" AND FILLED WITH FENTANYL 3000 MCG/ML ALONE. AFTER THE PT WAS DISCHARGED FROM THE HOSPITAL, SHE VISITED THE PUMP PHYSICIAN. THE PHYSICIAN WAS NO LONGER GOING TO MANAGE THE PUMP DUE TO THE PT'S COMPLEXITY. AS OF 01/27/2011, THE PT SUFFERED FROM WITHDRAWAL SINCE THE PUMP WAS "TURNED DOWN SO LOW".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MDT PUERTO RICO OPERATIONS CO., JUNCOS	8637-40	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Hospitalization\| R	IMPLANTED:\| EXPLANTED:\| CATHETER: MODEL 8709SC, LOT # N185129006