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

Model Number	46442
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see report number mw5074774.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was scheduled for a craniotomy for an aneurysm clipping on (b)(6) 2017.As part of the surgery preparation, the patient was having a lumbar drain placed, so they were positioned laterally.After a couple of attempts by the health care provider (hcp), the catheter was pulled out but the product broke and a piece was left inside of the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the physician documentation only stated "the doctor tried to put the lp catheter.Lum bar catheter approach was not successful.A piece of the catheter was broken down, end up to stay behind.Following that, the patient was put on supine position." no cause was determined as well as no external/environmental/patient factors that may have led or contributed to the event.The patient was discharged on (b)(6) 2017 to their home with family.The patient was doing very well and continued to retain the catheter in the spine with no effect on their recovery.It was stated the patient was aware of the retained catheter as well as the doctors and family.No issues with this at this time as it had not impeded their ability to recover.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7331103
• Report Number: 2021898-2018-00133
• Device Sequence Number: 18858086
• Product Code: GWM
• UDI-Device Identifier: 20643169471522
• UDI-Public: 20643169471522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: 03/31/2022
• Device Model Number: 46442
• Device Catalogue Number: 46442
• Device Lot Number: 213054673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 112