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

Model Number	46128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient underwent a lumbar drain.A pressure cable was not hooked up to the patient upon admission and when connected, the drain was not able to be zeroed or show a waveform, despite changing out the pressure cable and ¿pdm brick.¿ when attempting to zero, the monitor displayed a message saying ¿pressure sensed.¿ anesthesia called and was at beside along with the sicu team.Further troubleshooting was attempted with no success.Eventually, using a sterile technique, the transducer on the lumber drain was replaced with another one from an a-line setup and was able to get waveform to transduce pressure.This process took about two hours to figure out, during which the patient was unable to have csf drained.

• Brand Name: BECKER 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: 8167735
• Report Number: 2021898-2018-00563
• Device Sequence Number: 16420664
• Product Code: GWM
• UDI-Device Identifier: 00673978228754
• UDI-Public: 00673978228754
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2018

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: 04/16/2023
• Device Model Number: 46128
• Device Catalogue Number: 46128
• Device Lot Number: 215415619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1