MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY 1 X 3 DUREPAIR DURA SUBSTITUTE

Catalog Number 62106

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/09/2013

Event Type  Injury  

Event Description

It was reported to medtronic neurosurgery that expired product was implanted in the patient.According to the report, the product did not look or act faulty.The report stated that the patient had an existing dural leak from a prior surgery.Reportedly, the purpose of the durepair was to try and fix the csf leak.According to the report, the patient was still leaking csf and underwent surgery by another physician.Reportedly, the patient has been discharged.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: 1 X 3 DUREPAIR DURA SUBSTITUTE
• Type of Device: DURA SUBSTITUTE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 3557624
• MDR Text Key: 4079642
• Report Number: 2021898-2014-00001
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 62106
• Device Lot Number: 1103038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention