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

Catalog Number	42955
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received reported the patient did not have an adjustment or mri while the device was implanted.Patient weight at implant provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the valve failed and was explanted.According to the report, there was no injury to the patient.
Additional Manufacturer Narrative
Additional information received reported the patient did not have an adjustment or mri while the device was implanted.Patient weight at implant provided.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.

• Brand Name: STRATAMR VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6337524
• Report Number: 2021898-2017-00061
• Device Sequence Number: 868854
• Product Code: JXG
• UDI-Device Identifier: 00643169692718
• UDI-Public: 00643169692718
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2017

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: 42955
• Device Lot Number: E12753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: 07/03/2017; 07/03/2017
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 08/02/2017; 09/29/2017
• 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
• Patient Age: 8 YR
• Patient Weight: 32