FDA Adverse Event Injury Summary report: N

INDURA

MDR report key: 1023432 · Received April 2, 2008

Report

Report Number: 2182207-2008-01724
Event Type: Injury
Date Received: April 2, 2008
Date of Event: May 8, 2005
Report Date: September 29, 2005
Manufacturer: MEDTRONIC, INC., NEUROLOGICAL DIVISION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. FINAL DEVICE ANALYSIS REVEALS CONNECTOR BROKEN AROUND SUTURE RING.

Description of Event or Problem · 1

THE HCP REPORTED THAT THE PT HAD A "LARGE POCKET OF CSF IN ABDOMEN". THE HCP REPORTED THAT PROBLEMS WITH PUMP "FLIPPING' WERE NOTED SINCE 2004. THE PT HAD LOST WEIGHT AND REQUIRED THAT THE PUMP TO BE TURNED RIGHT SIDE UP AT MANY REFILL APPOINTMENTS. 2005, EXTREME DIFFICULTY ACCESSING PUMP WAS ENCOUNTERED AND IT WAS ALSO SUSPECTED THAT THE CATHETER WAS TWISTED. OPTIMAL PAIN MANAGEMENT HAS "ALWAYS BEEN A CHALLENGE" FOR THIS PT. IN EARLY 2005 THE PT WAS TAKEN TO SURGERY WHERE THE PUMP WAS REANCHORED AND THE CATHETER WAS REPAIRED. AT THAT TIME IT WAS UNCERTAIN IF THE CATHETER WAS INTRATHECAL. THE SYSTEM WAS FOUND TO BE "INACT WITH GOOD FLOW OF FLUID". THE PUMP WAS RESTARTED SEVERAL DAYS LATER AND THE PT WAS GETTING GOOD ANALGESIC BENEFIT. APPROXIMATELY 3 WEEKS LATER, THE PT PRESENTED IN THE EMERGENCY ROOM WITH A "GROSSLY INFECTED WOUND (PUMP SITE). STARTED ON ANTIBIOTICS. INFECTION UNCONTROLLED AND PUMP REMOVED." FINAL PT OUTCOME WAS NOT REPORTED. REFER TO MFR'S REPORT # 6000030200501266 FOR PREVIOUS REPORT OF INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INDURA		LKK	MEDTRONIC, INC., NEUROLOGICAL DIVISION	8703W	L35606

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	PUMP: MODEL # 8627\| IMPLANTED: