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
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Additional information received reported that only the valve was explanted.Both catheters intentionally remained implanted.The product testing is in progress.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6620906
• Report Number: 2021898-2017-00316
• Device Sequence Number: 13532160
• Product Code: JXG
• UDI-Device Identifier: 00643169010789
• UDI-Public: 00643169010789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 06/20/2017; 06/20/2017; 11/10/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/02/2017; 09/07/2017; 09/07/2017; 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention