MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46866
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099)
Date of Event	05/11/2018
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 had complex (very low pressure) hydrocephalus post-subarachnoid hemorrhage (sah).As part of the patient ¿s admission with the sah, the patient did experience a lung infection and urinary infection.It was stated the patient needed a near zero pressure shunt.The patient was implanted with shunt that was set to 0.5.Reportedly, the patient failed to improve after implant and was in-patient for ¿many weeks.¿ the patient ultimately proceeded to have a lumbar drain to remove more cerebrospinal fluid (csf).They were subsequently found to have a cerebrospinal fluid infection which led to shunt removal/insertion of the drain.At the shunt removal surgery, the valve was tested (at pressure setting 0.5) and found to have slow flow at 20 cm h2o, and ceased flowing at 15 cm h2o.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7602442
• Report Number: 2021898-2018-00292
• Device Sequence Number: 1396892
• Product Code: JXG
• UDI-Device Identifier: 00643169010680
• UDI-Public: 00643169010680
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 11/30/2018
• Device Model Number: 46866
• Device Catalogue Number: 46866
• Device Lot Number: E05052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/14/2018
• 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
• Patient Age: 79 YR
• Patient Weight: 40