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

Model Number	8784
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
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) 2018, information was received from a manufacturer representative (rep) regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump for chronic pain.On (b)(6) 2018, during a procedure, the collet on the connector pin was missing.It was not clear whether the collet was missing from the kit or whether it fell of when the kit was opened.They could not find the collet when they searched for it, but "it had not been near the incision when we discovered it was lost".There were no environmental, external, or patient factors that may have led or contributed to the issue.A connector from a catheter (8785) kit was used.The issue was resolved at the time of this report.The patient's status was alive - no injury.
Additional Manufacturer Narrative
(b)(4).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: 7842320
• Report Number: 3007566237-2018-02620
• Device Sequence Number: 2547815
• Product Code: LKK
• UDI-Device Identifier: 00643169359178
• UDI-Public: 00643169359178
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/08/2018

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: 07/17/2020
• Device Model Number: 8784
• Device Catalogue Number: 8784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR