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

Catalog Number	46700
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All edms devices are 100% leak tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient's primary disease was craniocerebral trauma.According to the report, po st-operative observation found leakage of the ¿drainage tube¿ causing the patient's ventricle to become a "cavity." reportedly, the physician replaced with a new ¿tube,¿ and the patient's current status was normal.
Additional Manufacturer Narrative
Additional information received reported the leak occurred at the patient line stopcock.Patient weight updated.The product testing is in progress.
Additional Manufacturer Narrative
The returned device was patent and also met the requirements for leak testing.There was proteinaceous debris noted within the device.A review of the manufacturing records showed no anomalies.All edms devices are 100% leak tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXACTA DRAINAGE SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6620895
• Report Number: 2021898-2017-00314
• Device Sequence Number: 10765006
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

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: 01/31/2021
• Device Catalogue Number: 46700
• Device Lot Number: 210788579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 07/05/2017; 07/05/2017; 07/05/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/02/2017; 08/01/2017; 10/04/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60