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

Model Number	27816
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported there was a ¿peritoneal complication.¿ no further information was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the peritoneal catheter was blocked.
Additional Manufacturer Narrative
Patient age is an approximation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the issue had been resolved.No further information was provided.

• Brand Name: STRATA II SNAP SHUNT, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7108339
• Report Number: 2021898-2017-00642
• Device Sequence Number: 19200525
• Product Code: JXG
• UDI-Device Identifier: 00643169010529
• UDI-Public: 00643169010529
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E05157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 04/05/2018; 05/17/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 05/02/2018; 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR