PERITONEAL CATHETER WITH BIOGLIDE, STANDARD, TRANSLUCENT, 90 CM

Report

Report Number: 2021898-2014-00166
Event Type: Injury
Date Received: May 20, 2014
Date of Event: March 24, 2014
Report Date: April 21, 2014
Manufacturer: MEDTRONIC NEUROSURGERY
Product Code: JXG
PMA / PMN Number: K951258
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF THE CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD A DECOMPRESSIVE CRANIECTOMY AND INTRACRANIAL HEMATOMA SURGERY DUE TO CEREBRAL HEMORRHAGE CAUSED BY TRAUMA. ACCORDING TO THE REPORT, THE PATIENT WAS FALLING DOWN DUE TO SEIZURES. THE REPORT STATED THAT THE PATIENT WAS SENT TO THE HOSPITAL AND SHUNT IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2014. ACCORDING TO THE REPORT, THE PATIENT¿S SYMPTOMS STILL REMAINED AND THE PATIENT HAD SEIZURES INTERMITTENTLY. THE REPORT STATED THAT THE PATIENT COULDN'T SPEAK CLEARLY AND WAS EXPERIENCING RIGHT LIMB MOVEMENT DISORDER PROGRESSIVELY. REPORTEDLY, PATIENT¿S SHUNT WAS EXPLANTED ON (B)(6) 2014. THE REPORT STATED THAT THE PERITONEAL CATHETER WAS BLOCKED. REPORTEDLY, THE PATIENT CONDITION IS OK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298490	PERITONEAL CATHETER WITH BIOGLIDE, STANDARD, TRANSLUCENT, 90 CM	SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS	JXG	MEDTRONIC NEUROSURGERY		D42531

Patients

Seq	Age	Sex	Outcome	Treatment
1	00045 YR		Hospitalization\| R