FDA Adverse Event Other Summary report: N

OLM INTRACRANIAL PRESSURE

MDR report key: 522562 · Received February 11, 2004

Report

Report Number
2023988-2004-00015
Event Type
Other
Date Received
February 11, 2004
Report Date
February 11, 2004
Manufacturer
INTEGRA NEUROCARE LLC
Product Code
GWM
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE NURSE INDICATED THE 110-4B IS BEING "RE-PROCESSED" AND USED TO MONITOR PRESSURE IN THE SHOULDER. THIS HAS BEEN ON-GOING SINCE 1995. THE NURSE DID NOT IMPLICATE ANY PT INJURY BUT DID VOICE CONCERN ON THE RE-PROCESSING OF THE DEVICE. THE DEVICE 110-4B IS A SINGLE USE DEVICE USED TO MEASURE INTRACRANIAL PRESSURE. THE SALES REP WILL BE VISITING THIS HOSP TO GATHER MORE INFO. ADD'L INFO WAS REC'D IN 2004. THE SALES REP WAS AT THE HOSP FOR A MEETING REGARDING THE USE OF THIS DEVICE. THE FOLLOWING WAS REC'D; IT HAS BEEN CONFIRMED THAT THE HOSP RE-USED THE TRANSDUCER TIPPED CATHETER. THE CATHETER WAS WIPED DOWN WITH ALCOHOL BEFORE IT WAS RE-USED. THE CATHETER WAS PLACED IN THE SUBACROMIAL SPACE IN THE SHOULDER TO MEASURE PRESSURE. ONCE THE PRESSURE WAS MEASURED, THE CATHETER WAS THEN REMOVED. THIS WAS CONDUCTED ON AN OUTPATIENT BASIS. IT IS NOT CLEAR HOW THE CATHETER WAS PLACED, SINCE THERE WAS NO MENTION OF THE BOLT. THERE HAS BEEN APPROX 1500 PTS WHO UNDERWENT THIS TYPE OF MONITORING. THE CONTACT AT THE HOSP IS REQUESTING THE FOLLOWING INFO: IS THERE A LUMEN IN THE CATHETER? IF SO, HOW BIG IS THE LUMEN? IS THERE POSSIBILITY THE PT'S FLUID/BLOOD CAN BE RETAINED IN ANY PART OF THE CATHETER? IS THERE A MEMBRANE (PERMEABLE, SEMI-PERMMEABLE, NON-PERMEABLE) IN ANY PART OF THE TRANSDUCER TIPPED CATHETER THAT WOULD STOP BACK-FLUSH OF PT'S BLOOD/FLUID OR SOME OTHER MECHANISM FOR THIS? THE HOSP IS CURRENTLY DOING A TRACING ON ALL OF THE PT'S WHO REC'D THIS TYPE OF MONITORING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OLM INTRACRANIAL PRESSURE NEURO MONITORING GWM INTEGRA NEUROCARE LLC * UNK

Patients

Seq Age Sex Outcome Treatment
1 *