FDA Adverse Event Malfunction Summary report: N

SYNCHROMED II

MDR report key: 2910534 · Received January 11, 2013

Report

Report Number: 3004209178-2013-00469
Event Type: Malfunction
Date Received: January 11, 2013
Report Date: December 19, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 8709, SERIAL #(B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N083573, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION REPORTED THE MAGNETIC RESONANCE IMAGE (MRI) WAS THOUGHT TO BE DUE TO AN ISSUE WITH THE PUMP.

Description of Event or Problem · 1

THE PATIENT HAD A PUMP REPLACEMENT IN AUGUST AND SINCE THAT TIME HER LEGS ARE NUMB INSTEAD OF HER BACK AND SHE CAN HARDLY WALK. AN MRI WAS BEING PERFORMED BECAUSE THE HCP SUSPECTED THAT THE CATHETER WAS NOT PLACED IN THE RIGHT SPOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED, THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE AND DILAUDID. IT WAS REPORTED, THE HEALTH CARE PROVIDER WAS UNSURE IF THE CAUSE OF THE EVENT WAS DUE TO THE DRUG BUPIVACAINE OR THE PATIENT'S LOWER BACK PROBLEMS. THE MRI WAS PERFORMED ON (B)(6) 2012 HOWEVER, THE RESULTS WERE NOT PROVIDED. IT WAS NOTED THE PATIENT EXPERIENCED WEAKNESS IN THEIR LEGS. THE PLAN WAS TO CONTINUE TO MONITOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17588	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1