FDA Adverse Event Malfunction Summary report: N

SYNCHROMED II

MDR report key: 1030948 · Received April 17, 2008

Report

Report Number: 3004209178-2008-02015
Event Type: Malfunction
Date Received: April 17, 2008
Date of Event: January 10, 2008
Report Date: March 19, 2008
Manufacturer: MEDTRONIC 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

FINAL DEVICE ANALYSIS REVEALS PUMP FLOW TESTED AT 24,000 UL/DAY AND 300 UL/DAY. AMOUNT DISPENSED WAS IN SPECIFICATION, BUT THE RESERVOIR PRESSURE WAS VERY LOW THROUGHOUT THIS TESTING. PERFORMED MULTIPLE REAL TIME X-RAYS REVEALING THAT THERE IS NOT SIGNIFICANT PROPELLANT IN THIS PUMP. THE PROPELLANT CAN BE SEEN IN A POOL OF LIQUID AT THE BOTTOM OF THE PUMP.

Description of Event or Problem · 1

THE HCP REPORTED THAT THE PT HAD IRREGULAR VOLUMES AT REFILLS DUE TO PROBLEMS WITH THE CATHETER. IT WAS REPORTED TO BE OCCLUDED, "PROBABLY TURNED AND KINKED" AND POSSIBLY DISPLACED FROM THE INTRATHECAL SPACE. THE CATHETER WAS REPLACED. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES DILAUDID. THE PUMP WAS ALSO REPLACED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS, ALTHOUGH THE HCP DID NOT SUSPECT IT WAS THE CAUSE OF THE VOLUME IRREGULARITIES. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. SEE ALSO MANUFACTURER'S REPORT#: 6000030-2008-00595.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MEDTRONIC PUERTO RICO OPERATIONS CO.	863720	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Required Intervention	IMPLANTED:\| EXPLANTED:\| CATHETER MODEL#: 8709 LOT#: N056895035\| PROGRAMMER MODEL 8840 LOT# UNK