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

Model Number	8781
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: neu_unknown_pump, product type: pump.
Event or Problem Description
On (b)(6) 2017, information was received from a foreign healthcare professional (hcp) via daiichi regarding a patient receiving an unknown drug from an implantable pump for an unknown indication.On (b)(6) 2017, while using the ascenda catheter (8781) at the operation, the catheter bent when "it was hard to raise near the th 11 in the intrathecal" space.It was stated, "it was useless".The hcp stated that "the guidewire was extremely weak compared with the conventional catheter and it was easy to bend." the customer wanted the catheter strength analyzed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2017, additional information was received from a foreign manufacturer representative (rep).Additional information confirmed that a new catheter was used.The device sn/model was unknown.Additional information also confirmed that the catheter issue did not result in any patient impact.
Additional Manufacturer Narrative
(b)(6).Analysis of the catheter identified that damage occurred to catheter body and-or guidewire during the implant procedure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2017-sep-04, additional information was received from a foreign manufacturer representative (rep).It reported the pump was used to deliver baclofen (unknown dose and concentration).It was asked if a new catheter was used and the rep stated, "a new catheter should have been used but cannot be confirmed." it was unknown if the catheter issue resulted in any patient impact.No further complications were reported and/or anticipated.

• 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: 6800658
• Report Number: 3007566237-2017-03339
• Device Sequence Number: 16403930
• Product Code: LKK
• UDI-Device Identifier: 00643169202139
• UDI-Public: 00643169202139
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2017

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: 11/15/2018
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N680972004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/04/2017; 09/27/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 09/26/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1