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

Catalog Number	27304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2017
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 catheters are 100% inspected 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 a patient presented to the clinic with gait disturbance.The patient had been doing well until 2 years ago when their legs just gave out.At that time, they were taken to the emergency department, but no etiology was identified.After that, the patient's gait and memory started to decline.They reported unsteadiness, but no falls.According to the report, the patient was referred for evaluation of nph and was admitted for a lumbar drainage as part of the evaluation.Neuroradiology placed a spinal needle and catheter under sterile conditions, but the catheter would not advance past the needle tip.The catheter was then removed intact.Reportedly, at the time, it was noted that a 1.5 mm region adjacent to the tip was torn.The team obtained images which did not reveal any catheter remnant.Of note, the catheter was radiopaque.The neurologist aspirated cerebrospinal fluid from the spinal needle and no remnant was found.Repeat imaging again did not reveal any remnants in the thecal sac.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6665273
• Report Number: 2021898-2017-00347
• Device Sequence Number: 16154732
• Product Code: GWM
• UDI-Device Identifier: 00673978246055
• UDI-Public: 00673978246055
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 12/31/2021
• Device Catalogue Number: 27304
• Device Lot Number: 212551530
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1