SYNCHROMED II

Report

Report Number: 3004209178-2014-09335
Event Type: Injury
Date Received: May 21, 2014
Date of Event: March 27, 2014
Report Date: April 30, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE CATHETER MOVED FROM T-9 TO THE S-2 LEVEL AT SOME POINT SINCE IMPLANT. IT WAS NOTED THE PATIENT HAD A SUCCESSFUL TRIAL, BUT NEVER REALLY RECEIVED EFFECT AFTER IMPLANT. IT WAS ALSO REPORTED A COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE AND THEY NOTICED THE CATHETER TIP HAD MOVED DOWN SO THEY REPLACED A SECTION OF THE SPINAL PORTION OF THE CATHETER. THE PUMP WAS BEING USED TO DELIVER GABLOFEN. IT WAS FURTHER REPORTED IT WAS UNKNOWN WHAT SYMPTOMS THE PATIENT WAS EXPERIENCING. THE OLD CATHETER WAS REMOVED FROM THE INTRATHECAL SPACE AND A NEW SPINAL SEGMENT WAS ADDED. IT WAS REPORTED A COLLET CONNECTOR PIN WAS USED TO JOIN THE CATHETERS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING INEFFECTIVE INTRATHECAL BACLOFEN (ITB) THERAPY. IT WAS ALSO REPORTED TROUBLESHOOTING INCLUDED AN X-RAY WHICH SHOWED THE CATHETER TIP AT ¿L1- INFERIOR EDGE,¿ COILING, AND THEREFORE IT WAS SUBSEQUENTLY REVISED. IT WAS NOTED THE PATIENT WAS DOING SLIGHTLY BETTER. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
302728	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC PUERTO RICO OPERATIONS CO.	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00069 YR		Required Intervention