MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, STANDARD, OPEN END, BARIUM IMPREGNATED, 120 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	23047
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	09/12/2018
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 that during a follow up appointment for a patient with post-hemorrhagic asymmetrical hydrocephalus, the doctor realized that the peritoneal catheter had exited through the anus of the patient.It was stated the catheter had perforated the intestine.The patient was well however.The catheter was explanted and the patient was connected to an external drainage system while liquid antibiotics were administered.While the patient was connected to the external drainage system, they could not stand up since the valve did not prevent overdrainage.The valve was also replaced.The patient¿s status was noted as alive; no injury.

• Brand Name: PERITONEAL CATHETER, STANDARD, OPEN END, BARIUM IMPREGNATED, 120 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8243398
• Report Number: 2021898-2019-00025
• Device Sequence Number: 2203301
• Product Code: JXG
• UDI-Device Identifier: 00643169483545
• UDI-Public: 00643169483545
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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: 12/31/2019
• Device Model Number: 23047
• Device Catalogue Number: 23047
• Device Lot Number: D73509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/14/2019
• 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: 16 YR
• Patient Weight: 55