FDA Adverse Event Malfunction Summary report: N

SYNCHROMED II

MDR report key: 3060265 · Received April 16, 2013

Report

Report Number: 3004209178-2013-06325
Event Type: Malfunction
Date Received: April 16, 2013
Report Date: March 29, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
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, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4). FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THE PUMP PASSED ALL NON-DESTRUCTIVE LAB TESTING. THERE WAS NO COMPLAINT AGAINST THE PUMP. THERE WAS A MOTOR STALL AND RECOVERY IN THE LOGS. DURING DESTRUCTIVE ANALYSIS THE TECHNICIAN FOUND SIGNIFICANT RESIDUE IN THE PINION AND ON THE LOWER SHAFT OF GEAR 2. AND ALSO FOUND SOME RESIDUE ON THE JEWEL WHERE THE LOWER SHAFT OF GEAR 2 INSERTS INTO THE BOTTOM BRIDGE ASSEMBLY. SEE PHOTOS REGARDING THIS ANALYSIS SUMMARY. FINAL DEVICE ANALYSIS OF THE CATHETER REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE CATHETER WAS INCOMPLETE AND RETURNED IN SEGMENTS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT DIED (B)(6) 2007. IT WAS NOTED THE PATIENT HAD CANCER OF THE BREAST AND HAD AN IMPLANTABLE INFUSION DEVICE WITH THE MEDICATION MORPHINE, FOR THE TREATMENT OF MALIGNANT PAIN. IT WAS NOTED THAT THE PUMP WAS EXPLANTED IN 2007 AFTER THE PATIENT DIED, AND LEFT RUNNING DRY UNTIL 2013. THERE WERE NO DEVICE ISSUES, NOR ANY PATIENT SYMPTOMS REPORTED. THE PHYSICIAN INDICATED HE DID NOT KNOW THE CAUSE OF DEATH, BUT "KNEW" IT WAS NOT RELATED TO THE DEVICE. HE HAD NO FURTHER INFORMATION TO PROVIDE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
162593	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	863740

Patients

Seq	Age	Sex	Outcome	Treatment
1	00053 YR