SYNCHROMED II

Report

Report Number: 3004209178-2012-11367
Event Type: Injury
Date Received: December 10, 2012
Date of Event: November 4, 2012
Report Date: November 9, 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: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L64338, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND A PUMP MOTOR FEED THRU ANOMALY, AND PUMP MOTOR GEAR TRAIN ANOMALY, WITH CORROSION, WEAR AND LUBRICATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S PUMP WENT INTO A SAFE STATE, THE PATIENT WENT INTO WITHDRAWAL, AND THE PUMP WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT WENT TO THE HEALTHCARE PROVIDER'S (HCP) OFFICE BETWEEN REFILLS AND WAS IN WITHDRAWAL. THE PATIENT WAS EXTREMELY AGITATED, AND HAD UNDERDOSE SYMPTOMS OF ALTERED MENTAL STATUS, PAIN AND SWEATING (DIAPHORESIS). THE HCP FOUND THE PUMP TO BE IN A SAFE STATE, WHICH OCCURRED ON (B)(6) 2012. THE HCP RESET THE PUMP ON (B)(6) 2012 AND SHORTLY AFTER THAT SAME DAY, IT REVERTED BACK TO SAFE STATE. IT WAS NOTED THAT WHEN THE HCP TRIED TO PROGRAM PUMP OUT OF A SAFE STATE, PUMP STARTED ALARMING. THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT THAT AFTERNOON. FOLLOWING THE REPLACEMENT, THE HCP WAS STARTING THE PATIENT AT A LOWER DOSE AND TITRATING UP TO A THERAPEUTIC DOSE. THE PATIENT WAS DOING FINE AFTER THE REPLACEMENT AND "RECOVERED WITHOUT SEQUELAE." THE MEDICATIONS IN THE PUMP WERE BUPIVACAINE, BACLOFEN AND MORPHINE. 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	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	863740

Patients

Seq	Age	Sex	Outcome	Treatment
1	00059 YR		Required Intervention