MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET EDMS, SMARTSITE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 46914

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

It was reported to medtronic neurosurgery that the patient line tubing connected to the ventricular catheter had disconnected from its distal luerlock connector.It was also reported that there was no patient injury and that he was in stable condition.

Manufacturer Narrative

The product was returned without the patient line assembly and drainage bag.Thus, laboratory personnel were unable to verify the conditions of the complaint.Additionally, the patency and leakage tests were precluded due to the device missing the patient connection line and drainage bag.A review of the manufacturing records was not possible as a lot number was not provided.(b)(4).

Manufacturer Narrative

The product was returned without the patient line assembly and drainage bag.Thus, laboratory personnel were unable to verify the conditions of the complaint.Additionally, the patency and leakage tests were precluded due to the device missing the patient connection line and drainage bag.A review of the manufacturing records was not possible as a lot number was not provided.(b)(4).

• Brand Name: DUET EDMS, SMARTSITE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• 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: 3673274
• MDR Text Key: 4297704
• Report Number: 2021898-2014-00067
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K983799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46914
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1921-2014
• Patient Sequence Number: 1
• Patient Age: 00047 YR
• Patient Weight: 65