FDA Adverse Event Injury Summary report: N

SYNCHROMED EL

MDR report key: 3973624 · Received August 1, 2014

Report

Report Number: 6000030-2014-00102
Event Type: Injury
Date Received: August 1, 2014
Report Date: July 8, 2014
Manufacturer: RICE CREEK MFG
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8711, LOT# J11155R43, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

THE CATHETER WAS NOT WORKING PROPERLY AS THERE WERE POTENTIAL KINKS IN THE DISTAL END OF THE SPINAL SEGMENT; SUBSEQUENTLY, THE PUMP HAD BEEN INACTIVE FOR SEVERAL YEARS. NO DIAGNOSTICS WERE PERFORMED ON THE PUMP. A CATHETER DYE STUDY WAS PERFORMED AND THE CATHETER WAS NOT FLOWING PROPERLY IN THE DISTAL SPINAL SEGMENT. ON (B)(6) 2014, THE ¿NEW¿ PHYSICIAN SUCCESSFULLY REMOVED THE OLD DEVICE AND A PORTION OF THE PUMP SEGMENT; HOWEVER, HE WAS UNABLE TO REMOVE ANY OTHER SPINAL OR PUMP PORTION OF CATHETER. A NEW PUMP AND CATHETER WERE IMPLANTED AND WAS FUNCTIONING AND INTACT. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE ISSUE RESOLVED AND THE PATIENT¿S STATUS WAS ALIVE ¿ NO INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION INDICATED THAT THE MAJORITY OF THE OLD CATHETER WAS LEFT IN THE PATIENT. THE EXPLANTED PRODUCTS WERE NOT AVAILABLE FOR RETURN AS THE HOSPITAL TAKES THEM. THE PATIENT WAS DOING WELL AND WAS EXPERIENCING PAIN RELIEF AND BENEFIT FROM PUMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
449905	SYNCHROMED EL	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	RICE CREEK MFG	862618

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention