MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8781
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
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
Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device.There was no drug being delivered.The reason for use was not reported.It was reported that during a trial for a pump implant on (b)(6) 2018, the doctor believed that the catheter kept kinking and was therefore defective.The catheter was part of a large shipment of pre-ordered products the hospital purchased.The facility is interested in a credit.Ultimately, the catheter was never used (never implanted) and discarded.The representative was unaware that the discarded product should be returned.The product was replaced with another of the same manufacturer.The issue was resolved at the time of the report.There were no symptoms reported.There were no environmental/external/patient factors that may have led or contributed to the issue.There were no diagnostics/troubleshooting performed.There were no further complications reported/anticipated.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8077612
• Report Number: 3004209178-2018-25579
• Device Sequence Number: 13782595
• Product Code: LKK
• UDI-Device Identifier: 00763000051129
• UDI-Public: 00763000051129
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/16/2018

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: 10/09/2020
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: HG2VD9M08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1