FDA Adverse Event Malfunction Summary report: N

CODMAN VPV SYSTEM

MDR report key: 4460073 · Received January 28, 2015

Report

Report Number: 1226348-2015-10062
Event Type: Malfunction
Date Received: January 28, 2015
Manufacturer: CODMAN & SHURTLEFF
Product Code: JXG
PMA / PMN Number: PK061876
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

GTIN: (B)(4). 510 (K) NUMBERS: K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EXAMINATION OF THE RETURNED VPV PROGRAMMER DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE PROGRAMMER WAS PLUGGED IN AND DISPLAYED ¿IMPLANTED VALVE PLEASE SELECT PRESSURE¿. THE PROGRAMMER WAS RESET. DIFFERENT TESTS WERE PERFORMED IN ACCORDANCE WITH OUR INTERNAL TEST METHOD. THE FUNCTIONALITY OF THE PRODUCT WAS VERIFIED PER SPECIFICATION. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

Description of Event or Problem · 1

THE VPV GAVE A ¿ADJUSTMENT COMPLETE¿ WHEN REPROGRAMMED. HOWEVER, WHEN XRAY CONFIRMED IT WAS NOT SET PROPERLY. AS A RESULT THE CLINICIAN KEPT REPROGRAMMING UNTIL XRAY SHOWED THE CORRECT SETTING. (B)(6) 2015 PER AFFILIATE: UNFORTUNATELY THE ACCOUNT COULD NOT GIVE ME AN EVENT DATE. THEY COULDN'T REMEMBER. THERE WAS NO ADVERSE AFFECT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
64633	CODMAN VPV SYSTEM	VALVE PROGRAMMER	JXG	CODMAN & SHURTLEFF

Patients

Seq	Age	Sex	Outcome	Treatment
1