MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CATHETER PASSER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8591-38
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
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
Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a catheter extension kit component.On (b)(6) 2019, it was reported that the tunneling rod handle cracked during tunneling.No patient symptoms were reported.No further complications were reported.
Additional Manufacturer Narrative
Information received on 2019-dec-16.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information wasreceived from the healthcare provider (hcp) via the manufacturer's representative on 2019-dec-16.It was reported that the patient did not experience any symptoms related to the tunneling tool handling cracking.The patient's weight at the time of the event was provided.
Additional Manufacturer Narrative
Analysis identified a crack in the plastic handle of the tunneling rod which is consistent with being caused by user handling.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHETER PASSER
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9475639
• Report Number: 2021898-2019-00437
• Device Sequence Number: 2648802
• Product Code: LKK
• UDI-Device Identifier: 00673978226842
• UDI-Public: 00673978226842
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2020

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: 06/30/2024
• Device Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: E68660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 02/24/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 12/17/2019; 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 68