FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3407834 · Received October 14, 2013

Report

Report Number: 3004209178-2013-19033
Event Type: Injury
Date Received: October 14, 2013
Report Date: September 25, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008; EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013; PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

A CEREBROSPINAL FLUID (CSF) SAMPLE WAS WITHDRAWN FROM THE CATHETER ONCE IT WAS DISCONNECTED FROM THE PUMP FOR CULTURE AND SENSITIVITY AND ¿SENT INTRA-OPERATIVELY FROM THE PUMP ABDOMINAL SITE¿. AFTER THE PUMP WAS REPLACED AND THE PATIENT WAS OUT FROM SURGERY, RESULTS OF STAPH AUREUS CAME BACK FROM THE LAB ON BOTH THE CSF SAMPLE AND WOUND CULTURE. THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM, AND THEIR ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2013. THE PATIENT REQUIRED HOSPITALIZATION. THE MEDICATION INFUSED WAS GABLOFEN. IT WAS LATER REPORTED THAT THE PUMP WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 IN STABLE CONDITION. THE PATIENT DID WELL WITHOUT ANY SIGNIFICANT ISSUES WITH PAIN OR BACLOFEN WITHDRAWAL. ANTIBIOTICS WERE DELIVERED VIA A PICC LINE. A PUMP AND CATHETER PLACEMENT WAS PLANNED IN A 4-6 WEEK TIME PERIOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
525939	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00009 YR		Hospitalization\| R