MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 27303

Device Problems Crack (1135); Fracture (1260)

Patient Problems Death (1802); Unspecified Infection (1930); Respiratory Failure (2484)

Event Date 02/01/2020

Event Type  Death  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Investigation results: based on the provided information within this complaint, there is not enough information to conclude that there is a manufacturing or design related non-conformance of the device.Limited details were provided to patient event specific factors.No causality between the patient reaction (death) and alleged product was noted in complaint nor could any conclusions be identified based on complaint details provided.With the available information, a contributing factor or cause for the reported event cannot be confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre op diagnosis: cerebral hemorrhage procedure performed: drilling and drainage of right lateral ventricle under general anesthesia intra-op, the patient was undertaken lumbar cistern drainage due to hydrocephalus.The process of placing the tube was smooth, the depth was adjusted during the surgery, and there was stuck when tube returned.After repeated adjustment of the angle, the returned tube was completely inspected, and a crack was found at the tip of the drainage tube, so a new drainage tube was replaced.The patient died due to intracranial infection, respiratory failure (death in the ward).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine,ca IN 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine,ca IN 92617
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine,ca, TN 92618 ; 9496801345
• MDR Report Key: 9943022
• MDR Text Key: 187023670
• Report Number: 1030489-2020-00432
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K802100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 215734579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 65