FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3072469 · Received April 23, 2013

Report

Report Number: 3007566237-2013-01392
Event Type: Injury
Date Received: April 23, 2013
Date of Event: March 26, 2013
Report Date: March 27, 2013
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, A BREAK IN THE DISTAL SEGMENT. DURING A PUMP REPLACEMENT FOR NORMAL BATTERY DEPLETION, THE HEALTH CARE PROVIDER (HCP) CUT THE PUMP CONNECTOR. THE HCP THEN PERFORMED A DYE STUDY TEST WHICH REVEALED THAT THERE WAS ALSO CUT IN THE SPINAL SEGMENT OF THE PATIENT'S CATHETER. THE HCP TRIED TO EXTRACT THE SPINAL SEGMENT BUT "DURING OPERATION" THE CATHETER WAS BROKEN AND "A LITTLE FRAGMENT OF THE SPINAL SEGMENT" WAS LEFT IN THE PATIENT'S BODY. IT WAS REPORTED THE HCP DECIDED TO REPLACE BOTH THE PUMP AND SPINAL SEGMENT WITH TRICUMED DEVICES. IT WAS NOTED THE PATIENT NEVER HAD ANY SYMPTOMS OF WITHDRAWAL PRIOR TO THE REPLACEMENT AS WELL AS AFTER. THE DEVICE SYSTEM HAD BEEN USED TO ADMINISTER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT WOULD BE MONITORED DURING THE NEXT FOLLOW UP OF THE PUMP. THE IMAGES OF THE DYE TEST WERE NOT AVAILABLE AND IT WAS NOTED THE HCP HAD DECIDED TO EXPLANT THE CATHETER BECAUSE HE PREFERRED TO EXPLANT IT TO AVOID HAVING TO MAKE A REVISION IN THE FUTURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
174347	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC NEUROMODULATION	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other