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

Model Number	8782
Medical Device Problem Codes	Connection Problem (2900); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
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
On (b)(6) 2020, information was received from a manufacturer representative (rep) regarding the use of an 8782 catheter revision kit.No patient involvement reported.No symptoms or patient complications reported.It was reported the rep had an out of box failure with a catheter revision kit.The healthcare professional (hcp) was not able to slide the connector onto the intrathecal segment so they opened another box and that one slid on just fine.
Additional Manufacturer Narrative
The evaluation code has been updated for this event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from the manufacturer's representative (rep).The rep reported the device had been discarded.

• 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: 9700412
• Report Number: 3004209178-2020-03174
• Device Sequence Number: 19438647
• Product Code: LKK
• UDI-Device Identifier: 00763000051136
• UDI-Public: 00763000051136
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 03/06/2021
• Device Model Number: 8782
• Device Catalogue Number: 8782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1