FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3151069 · Received June 6, 2013

Report

Report Number: 3004209178-2013-08761
Event Type: Injury
Date Received: June 6, 2013
Report Date: May 13, 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: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY TO RELOCATE THE PUMP. IT WAS STATED THE PUMP HAD BEEN MOVING IN THE POCKET. IT WAS SPECIFICALLY STATED THAT IT ¿JUST KIND OF BLEW RIGHT OUT OF THERE AND WAS FLAPPING AROUND CAUSING ALL KINDS OF PROBLEMS¿. THIS WAS REPORTEDLY AN EMERGENCY AND THE PATIENT HAD BEEN INSTRUCTED TO CALL THE SURGEON ON THE DAY FOLLOWING THE DISCOVERY OF THE ISSUE. THE PATIENT WAS ABLE TO GO HOME THE SAME DAY AS THE SURGERY. IT WAS NOTED THAT THE PATIENT HAD LOST WEIGHT SINCE IMPLANT, GOING FROM (B)(6) POUNDS. IT WAS STATED THAT THE PUMP HAD BEEN RELOCATED TO THE LOCATION WHERE IT SHOULD HAVE ORIGINALLY BEEN PLACED. AT THE TIME OF REPORT, THE PATIENT WAS STILL IN SOME PAIN AND THE SURGERY STRIPS WERE STILL IN PLACE. THE DEVICE SYSTEM WAS DELIVERING FENTANYL, BUPIVACAINE, AND ANOTHER UNKNOWN DRUG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
249812	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention