MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8781
Medical Device Problem Codes	Bent (1059); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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
Information was received from a foreign healthcare provider (hcp) via a manufacturers representative regarding a patient who was receiving an unknown drug via an implantable pump.It was reported that when the pump catheter and spinal catheter were being connected with the catheter connector, they couldnt be connected.The metal on the part that the catheter is inserted into was bent.The hcp had seen this problem before, and because it happened again, it was commented that this seemed to be happening a lot.The accessory kit was opened and the connection was able to be done without any problems using the connector inside the kit.There were no reported symptoms.
Additional Manufacturer Narrative
Analysis of the catheter, model# 8781, serial# (b)(4), found the distal side of the pin connector to be bent after removing the collet.There was no damage to the collet, lock tab, or detent tabs.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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6089787
• Report Number: 3007566237-2016-03986
• Device Sequence Number: 19116632
• Product Code: LKK
• UDI-Device Identifier: 00613994555601
• UDI-Public: 00613994555601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2016

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: 03/31/2018
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N627462002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 12/07/2016
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 12/07/2016; 12/08/2016; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1