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

Model Number	8781
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
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
Additional information was received.It was previously reported that the implant date of the catheter was (b)(6) 2019.Additional information received reported that the catheter was implanted on (b)(6) 2019.Further information of the event was provided and reported that the event occurred when the spinal catheter was inserted into the medullary cavity and the catheter was removed from the groove of the guidewire handle to extract the guidewire in the catheter.There were no reported or anticipated complications.
Additional Manufacturer Narrative
Analysis confirmed there was foreign material inside the sterile packaging.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving an unknown drug with an unknown concentration and unknown daily dose via an implantable pump for an unknown indication for use.It was reported that when removing the guidewire from the catheter, the catheter was removed from the guidewire handle and the guidewire without the catheter was removed.When removing the catheter from the guidewire handle, something white dropped at the same time.There were no reported patient symptoms.It was reported that no health damage to the patient was reported.There were no reported or anticipated complications.
Additional Manufacturer Narrative
Fdc updated.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9355656
• Report Number: 3004209178-2019-22332
• Device Sequence Number: 2242874
• Product Code: LKK
• UDI-Device Identifier: 00763000051129
• UDI-Public: 00763000051129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: 11/28/2020
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: HG2ZMB513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 12/19/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/22/2019; 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1