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

Model Number	8781
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_pump, serial# unknown, product type pump.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2017, information was received from a foreign healthcare professional (hcp) via (b)(6).No patient information or drug information was received.On (b)(6) 2017, during an operation, the spinal catheter and the pump catheter were attempt to be connected using a catheter connect (collet), but one side of the collet was tight so that the catheter was unable to be inserted properly.Details of the actual product of complaint stated, "regarding one side of the collet, the catheter was inserted in the whole and locked.The other side of the collet which was tight was already locked as well.The physician was well experienced as he performed the procedure in more than 15 cases." because the catheter was unable to be inserted properly, a catheter connector in an accessory kit was unpacked and used.No further information was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2017, an update to the "written expression of the sentence "details of the actual product of complaint" was slightly changed" to "the catheter was unable to be connected".
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 healthcare professional (hcp) via a manufacturer representative (rep) and (b)(4).It reported the patient was receiving baclofen (no reported dose or concentration).Patient information was requested, but was not provided by (b)(4).
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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The previously reported no longer applies to this event.Analysis of the catheter (lot # n736022005) identified that the catheter was not fully seated onto the connector and the collet was locked in place.The catheter was returned in segments and was found to be patent.No leaks were identified.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: 7072951
• Report Number: 3007566237-2017-05016
• Device Sequence Number: 1450703
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/19/2018

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: 07/06/2019
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N736022005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 12/05/2017; 12/06/2017; 12/13/2017; 01/15/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/06/2017; 12/07/2017; 12/13/2017; 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1