FDA Adverse Event Malfunction Summary report: N

MICRO VENTRICULAR BOLT ICP MONITORING KIT

MDR report key: 3042958 · Received April 4, 2013

Report

Report Number: 2023988-2013-00007
Event Type: Malfunction
Date Received: April 4, 2013
Date of Event: February 25, 2013
Report Date: April 4, 2013
Manufacturer: INTEGRA NEURO SCIENCES CA/USA
Product Code: GWM
PMA / PMN Number: K914735
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

Description of Event or Problem · 1

A PT (B)(6) WAS STATUS POST A FALL FROM A HORSE. A VENTRICULOSTOMY CATHETER AND A CAMINO MONITORING SYSTEM WERE INSERTED INTO THE PT'S BRAIN ON (B)(6) 2013. THE PT'S CONDITION IMPROVED AND THE UNIT WAS BEING REMOVED ON (B)(6) 2013. UPON REMOVAL THE BOLT WAS REMOVED WITH THE FIBEROPTIC CATHETER INTACT, HOWEVER A PORTION OF THE VENTRICULAR CATHETER REMAINED IN THE PT'S BRAIN. THE NURSE PRACTITIONER ATTEMPTED TO OPEN THE INCISION AND LOOK INTO THE BURR HOLE BUT DID NOT VISUALIZE THE CATHETER. THE INCISION WAS STAPLED CLOSED THE NEUROSURGEON WAS NOTIFIED. THE RETAINED PIECE WAS CONFIRMED BY CT SCAN THE NEXT DAY. THE PT RETURNED TO SURGERY FOR A RIGHT FRONTAL BURR HOLE AND SUBSEQUENT RETRIEVAL OF THE RETAINED VENTRICULAR CATHETER. THE ENTIRE PIECE WAS RETRIEVED AND THE PT OTHERWISE HAD NO ADVERSE OUTCOME. THE PT'S FINAL OUTCOME WAS; THE PT'S NEUROLOGICAL STATUS IMPROVED AND HE WAS DISCHARGED TO INPATIENT REHABILITATION AND THEN DISCHARGED HOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
138589	MICRO VENTRICULAR BOLT ICP MONITORING KIT	N/A	GWM	INTEGRA NEURO SCIENCES CA/USA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention