FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 1870416 · Received October 11, 2010

Report

Report Number: 3004209178-2010-07815
Event Type: Injury
Date Received: October 11, 2010
Date of Event: July 16, 2010
Report Date: July 6, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURE FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD A PROBLEM WITH THIS CATHETER. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. MORE MEDICINE WAS ASPIRATED DURING A REFILL THAN WAS REPORTED AS PRESENT ON THE PROGRAMMER. A DYE STUDY WAS PERFORMED BUT SHOWED "NOTHING OF SIGNIFICANCE" PER THE HEALTH CARE PROFESSIONAL. THE PATIENT HAD ANXIETY AND WITHDRAWAL SYMPTOMS. A REVISION WAS PERFORMED WHERE THE CATHETER WAS EXPLANTED AND REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MDT PUERTO RICO OPERATIONS CO., JUNCOS	8637-40	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention	IMPLANTED:\| CATHETER: MODEL 8711, LOT # J11414R07\| EXPLANTED: