FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 2964073 · Received February 15, 2013

Report

Report Number: 3007566237-2013-00506
Event Type: Injury
Date Received: February 15, 2013
Date of Event: January 29, 2013
Report Date: January 29, 2013
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J10856R33, IMPLANTED: (B)(6) 2001, PARTIALLY OR ENTIRELY EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S PUMP WAS DUE TO BE REPLACED, AND DURING THAT PROCEDURE, THE HEALTHCARE PROVIDER (HCP) DETERMINED THE CATHETER WAS NO LONGER FUNCTIONING AND THE PUMP WAS THEN EXPLANTED. DURING THE PUMP REPLACEMENT PROCEDURE, THE HCP COULD NOT ASPIRATE THE CATHETER, AND IT IS UNCLEAR WHERE THE OCCLUSION OR BREAK WAS. BECAUSE OF THE PATIENT'S HEALTH CONCERNS, THE HCP THOUGHT IT WAS TOO RISKY TO REPLACE THE OLD CATHETER WITH A NEW CATHETER, AND THEREFORE DECIDED TO EXPLANT THE PUMP AND CATHETER WITHOUT REPLACING EITHER DEVICE. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. THE INFORMATION REPORTED INDICATED THE CATHETER WAS CAPPED, ABANDONED OR PARTIALLY REMOVED, THEREFORE A CATHETER OR CATHETER FRAGMENT REMAINED IMPLANTED. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS BACLOFEN. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
68406	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC NEUROMODULATION	863740

Patients

Seq	Age	Sex	Outcome	Treatment
1	00021 YR		Required Intervention