MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LP SHUNT KIT WITH CLOSED TIP LUMBAR CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 44421

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.All catheters are 100% inspected at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to medtronic neurosurgery that cerebrospinal fluid did not flow normally even then the pressure level was 0.5.According to the report, it was suspected there was a malfunction within the valve.The device was replaced with another manufacturer¿s device and a partial explant was noted.Reportedly, there was no patient impact.

Manufacturer Narrative

Additional information received reported that only the valve was explanted.Both catheters intentionally remained implanted.The product testing is in progress.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

The valve was dissected to investigate the cause of the event described by the surgeon.The ruby ball was still lodged into the cone upon disassembly, and the large amounts of biological debris is believed to be the reason why the ball remained lodged into the cone, which resulted in the occluded behavior noted by the surgeon that resulted in an inability for csf to flow through the valve mechanism.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LP SHUNT KIT WITH CLOSED TIP LUMBAR CATHETER
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 6620906
• MDR Text Key: 76942743
• Report Number: 2021898-2017-00316
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169010789
• UDI-Public: 00643169010789
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 44421
• Device Lot Number: E13761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention