PUDENZ PERITONEAL CATHETER, MEDIUM PRESSURE
Received Sep 20, 1999 · Event occurred Aug 9, 1999
Report 2132740-1999-00025 · MDR key 241350
Device
Generic name
Catheter
Manufacturer
Integra Neurocare Llc Heyer SchulteModel number
NACatalog number
NL850-1391
Lot number
UNK
Product problems
- Break
- Replace
Patient
27 YR
- Headache
- High Blood Pressure/ Hypertension
- Surgical procedure, repeated
- Respiratory Distress
- Tachycardia
- Other (for use when an appropriate patient code cannot be identified)
- Nonresorbable materials, unretrieved in body
- Therapy/non-surgical treatment, additional
- Cognitive Changes
- Treatment with medication(s)
- Manual ventilation required
Narrative
Description of Event or Problem
PT WAS ADMITTED TO THE EMERGENCY ROOM ON 08/09/1999. SYMPTOMS INCLUDED HEADACHE AND PHOTOPHOBIA. PT HAD PREVIOUSLY TAKEN OVER THE COUNTER HEADACHE REMEDY WITH NO RESULTS. MD NOTED THAT THE PT BECAME SOMNAMBULENT DURING EXAM. PT EXHIBITED TACHYCARDIA, SYSTOLIC BLOOD PRESSURE OVER 200, AND REQUIRED MANUAL BREATHING ASSISTANCE. USER FACILITY INDICATED A CT SCAN OF THE HEAD WAS PERFORMED WHICH SHOWED INCREASE VENTRICLE SIZE. NO INFO WAS AVAILABLE REGARDING THIS PT. PT RESPONDED POSITIVELY WHEN MD REMOVED A VOLUME OF CSF FROM THE SHUNT WITH A SPINAL NEEDLE. THE PT WAS TAKEN TO SURGERY, AND THE ENTIRE SHUNT SYSTEM, CONSISTING OF A VENTRICULAR CATHETER, A SHUNT, AND A PERITONEAL CATHETER WERE REMOVED AND REPLACED. DURING REMOVAL FROM THE PERITONEUM THE TIP OF THE PERITONEAL CATHETER WAS BROKEN OFF, AND REMAINS IN THE PT. THE PT WAS OBSERVED FOR 2 DAYS AFTER THE REMOVAL AND REPLACEMENT OF THE SHUNT SYSTEM, AND THEN DISCHARGED TO HOME ON 08/11/1999.