MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8781
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
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 professional (hcp) via a company representative regarding a catheter.The hcp thought there was an issue with the catheter connector collet.Per the hcp, the connection pin site was defective, so the catheter was not implanted.Per the hcp, the two ends of the collet groove slide pieces where the catheter slips into place were not symmetrical.The hcp also didn't think the catheter connector with the two collets on the side should have the space in the middle.No further complications were reported/anticipated.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8243493
• Report Number: 3004209178-2019-00859
• Device Sequence Number: 14097044
• Product Code: LKK
• UDI-Device Identifier: 00763000051129
• UDI-Public: 00763000051129
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 01/14/2019

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: 11/28/2020
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1