MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR SHUNT ASSEMBLY, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	46955
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product testing is in progress.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the pressure setting could not be changed.According to the report, an anomaly of the part for pressure adjustment was suspected.It was stated that overdrainage was prevented by the patient keeping their head up.Reportedly, the device was explanted.
Additional Manufacturer Narrative
Additional information received reported there was no impact to the patient and they were under follow up.According to the report, no mris were performed while the device was implanted.The valve was not bathed in chemicals or antibiotics prior to implant.It was also noted that the setting was confirmed via x-ray after explant.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was received on march 9, 2017.The device was returned at pl setting 0.5.The device was preliminarily tested and reviewed by r <(>&<)>d in the device analysis lab.The r<(>&<)>d testing failed and r<(>&<)>d requested the device to be put on ¿hold¿ prior to final analysis testing.When the final device analysis was set to take place the device could not be located in the device analysis lab.A thorough search of the device analysis lab was conducted and the device could not be located.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATAMR SHUNT ASSEMBLY, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6395323
• Report Number: 2021898-2017-00107
• Device Sequence Number: 38596
• Product Code: JXG
• UDI-Device Identifier: 00643169593442
• UDI-Public: 00643169593442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2017

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: 05/31/2019
• Device Catalogue Number: 46955
• Device Lot Number: E12752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided; 03/14/2017; 10/20/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/13/2017; 09/06/2017; 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1702-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention