MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, CONTOURED SMALL, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bacterial Infection (1735); Vomiting (2144)
Date of Event	02/20/2017
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 on (b)(6) 2017, the patient presented with vomiting and abdominal pain and without headaches or change in mental status.They were found to have a small-bowel obstruction and was brought to the operating room to determine the cause of the bowel obstruction and to rule out shunt infection.The patient had a laparotomy where 2 pieces of the ventriculoperitoneal (vp) shunt tubing were exteriorized.One was dripping cerebrospinal fluid, and the other was with no evidence of any drainage.The doctor obtained a stat cerebrospinal gram stain and culture to evaluate for infection.The cerebrospinal fluid sent from the operation revealed no evidence of infection, with a negative gram stain and clean profile; however, on the morning of (b)(6) 2017, the cerebrospinal fluid from that surgery began growing staphylococcus.The patient's left parietal vp shunt was removed and replaced with a left parietal external ventricular drain.They also underwent iv antibiotic therapy after the picc line was placed as well as required a platelet transfusion prior to the procedure.

• Brand Name: CSF-FLOW CONTROL VALVE, CONTOURED SMALL, MEDIUM PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8697898
• Report Number: 2021898-2019-00233
• Device Sequence Number: 1888820
• Product Code: JXG
• UDI-Device Identifier: 00643169466487
• UDI-Public: 00643169466487
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 42314
• Device Catalogue Number: 42314
• Device Lot Number: E19597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/13/2019
• 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: 12 YR