MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Catalog Number	27304
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
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.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 to medtronic neurosurgery that there was leakage at the three-way valve during the procedure.According to the report, the system was replaced and there was no injury to the patient.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6729974
• Report Number: 2021898-2017-00391
• Device Sequence Number: 10968193
• Product Code: GWM
• UDI-Device Identifier: 00673978246055
• UDI-Public: 00673978246055
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K802100
• 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
• Report Date (Section B): 06/21/2017

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: 27304
• Device Lot Number: 210821534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 72