FDA Adverse Event Malfunction Summary report: N

SYNCHROMED II

MDR report key: 4862010 · Received June 23, 2015

Report

Report Number: 3004209178-2015-12033
Event Type: Malfunction
Date Received: June 23, 2015
Report Date: June 15, 2015
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER; PRODUCT ID 8835, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO ISSUE. THE PATIENT THOUGHT THEY HAD MORE BOLUSES IN A 24 HOUR PERIOD THAN WHAT WAS PROGRAMMED. THERE WERE NO SYMPTOMS ASSOCIATED WITH THE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE SEEMED TO STOP FOR 24 HOURS FOR SOME REASON. THE DEVICE RESUMED NORMAL FUNCTION AFTER AN INTERROGATION. THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER¿S REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2015 WAS PROVIDED. THE PUMP WAS USED TO INFUSE BUPIVACAINE AND MORPHINE. NO INTERVENTIONS, PATIENT SYMPTOMS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
407267	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00062 YR