MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46700
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was patent.It did not meet the requirements for leak testing due to a crack observed at the zero point reference stopcock.It is unknown how or when this damage occurred.All edms devices are 100% leak tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the procedure, when connecting the catheter to the drainage system, the doctor found leakage at the ¿three-way¿ connector.The drainage system was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
Patient age and weight updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the leakage occurred at the "joint." the cause of the leakage was not determined.

• Brand Name: EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6882759
• Report Number: 2021898-2017-00482
• Device Sequence Number: 19003629
• Product Code: GWM
• UDI-Device Identifier: 00643169707665
• UDI-Public: 00643169707665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983799
• 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): 11/03/2017

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: 09/30/2021
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 212095743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 65