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

Model Number	42955
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Ambulation or Postural Difficulties (2544)
Date of Event	10/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient presented with a history of normal pressure hydrocephalus with placement of ventriculoperitoneal shunt.The patient continued to suffer difficulty with headaches and balance.The valve that had been placed had subsequently been recalled.Based on the patient's failure to improve in the recall of the valve, the surgeon recommended for interrogation and possible revision of the ventriculoperitoneal shunt.As a result, the valve was explanted and replaced with another manufacturer's device.It was stated the patient was doing well, and their headache was slightly improved post-operatively.

• 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: 9771662
• Report Number: 2021898-2020-00073
• Device Sequence Number: 2704302
• Product Code: JXG
• UDI-Device Identifier: 00643169692718
• UDI-Public: 00643169692718
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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 Model Number: 42955
• Device Catalogue Number: 42955
• Device Lot Number: E12556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/28/2020
• 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: 70 YR
• Patient Weight: 88