SYNCHROMED II

MDR report key: 1901987 · Received November 12, 2010

Report

Report Number: 3004209178-2010-09395
Event Type: Injury
Date Received: November 12, 2010
Date of Event: October 20, 2010
Report Date: October 27, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - DIFFICULTY SWALLOWING - (B)(4).

Description of Event or Problem · 1

THE PT WAS RECEIVING EFFICACIOUS THERAPY UNTIL THE PT WAS ADMITTED TO THE HOSPITAL (B)(6) 2010 FOR DIFFICULTY SWALLOWING, RESPIRATORY DISTRESS AND INCREASED TONE. ACUTE WITHDRAWAL SYMPTOMS WERE NOTICED A DAY LATER ON (B)(6) 2010. THE PT WAS TAKING ORAL BACLOFEN EVERY 4 HOURS. THE PUMP DELIVERED LIORESAL 2000 MCG/ML AT 319 MCG/DAY. THE PUMP'S DAILY INFUSION RATE WAS INCREASED WITH NO IMPROVEMENT IN TONE. A CATHETER REVISION WAS PERFORMED (B)(6) 2010. DURING SURGERY, FREE FLOWING RETROGRADE CSF (CEREBROSPINAL FLUID) WAS OBSERVED FROM THE CATHETER. THE HCP MADE A SPINAL INCISION AND CUT THE CATHETER AT THE SPINE WHERE IT EXITED AND ALSO OBTAINED A FREE FLOW OF RETROGRADE CSF. THE PROXIMAL SEGMENT OF THE CATHETER ONLY WAS REPLACED, LEAVING IN THE EXISTING SPINAL SEGMENT FROM THE ORIGINAL (B)(4). AN (B)(4) WAS SPLICED ONTO THE EXISTING SPINAL SEGMENT AND TUNNELED OVER TO THE PUMP. THE PT, POSTOPERATIVELY, WAS STARTED ON A LOWER PUMP INFUSION RATE OF 270 MCG EVERY DAY. THE PT WAS SEEN BY THE HCP ON (B)(6) 2010. THE PT WAS DOING VERY WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MDT PUERTO RICO OPERATIONS CO., JUNCOS	8637-20	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	3 YR		Hospitalization\| O	EXPLANTED:\| IMPLANTED:\| CATHETER: MODEL 8709SC, LOT# N236687002