MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, STANDARD, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	43522
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 that the physician seen rapid obstructions due to graphite granulomas at the distal ends of the peritoneal catheter.
Additional Manufacturer Narrative
Additional information received and captured under regulatory reports 2021898-2019-00278 and 2021898-2019-00279.Any further information for the event will be reported under the referenced reports.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERITONEAL CATHETER, STANDARD, 90 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8383305
• Report Number: 2021898-2019-00082
• Device Sequence Number: 11270023
• Product Code: JXG
• UDI-Device Identifier: 00643169497122
• UDI-Public: 00643169497122
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 01/31/2023
• Device Model Number: 43522
• Device Catalogue Number: 43522
• Device Lot Number: E42443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1