FDA Adverse Event Injury Summary report: N

HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

MDR report key: 1172095 · Received September 23, 2008

Report

Report Number: 1226348-2008-00247
Event Type: Injury
Date Received: September 23, 2008
Date of Event: August 25, 2008
Manufacturer: CODMAN & SHURTLEFF, INC./MEDOS S.A.
Product Code: JXG
PMA / PMN Number: K974739
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICES WHICH HAVE INTERFERED WITH THEIR PROGRAMMING AND/OR PRESSURE CONTROL MECHANISMS. THE BIOLOGICAL DEBRIS HAS CAUSED THE RETURNED VALVES TO FAIL THE PROGRAMMING AND/OR PRESSURE TESTS AND APPEARS TO HAVE CAUSED THE DIFFICULTIES EXPERIENCED BY THE CUSTOMERS. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFO REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

Description of Event or Problem · 1

AFFILIATE REPORTED THAT THE DEVICE WOULD NOT REPROGRAM AFTER IMPLANTATION LEAVING THE SURGEON DOUBTFUL OF THE ACCURACY OF THE PRESSURE SETTING AS WELL AS THE AMOUNT OF FLUID FLOWING THROUGH THE VALVE. THE DEVICE NEEDED TO BE REPLACED. THE PROGRAMMER 82-3120 WAS USED. THE DEVICE WAS IMPLANTED IN 2001, AND REPLACED IN 2008.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER	SHUNT, CENTRAL NERVOUS SYSTEM & COMPS	JXG	CODMAN & SHURTLEFF, INC./MEDOS S.A.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	9 YR		Required Intervention