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

Model Number	8781
Medical Device Problem Codes	Connection Problem (2900); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
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
Information was received from a healthcare provider via a company representative regarding a patient receiving lioresal 2000 mcg/ml at 150 mcg / day via an implantable pump.The indications for use were not reported.It was reported that the healthcare provider was unable to get the spinal section of the catheter onto the connection pin.The healthcare provider made several attempts without being successful.At some point the collet on the spinal side fell apart from the rest of the connector.When asked if there were any environmental, external or patient factors that may have led or contributed to the issue the reporter did not believe the healthcare provider handled the catheter or the connector roughly.There was no troubleshooting performed.The company representative went and got an 8785 to replace the broken connector.The issue was resolved at the time of the report.The patient status was noted as alive, no injury and no further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis of the catheter found that the collet was detached from the catheter to catheter connector when it was returned to the manufacturer.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: 6962895
• Report Number: 3007566237-2017-04479
• Device Sequence Number: 633856
• Product Code: LKK
• UDI-Device Identifier: 00643169202139
• UDI-Public: 00643169202139
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 06/26/2019
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR