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

Model Number 8780

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving 500 mcg/ml gablofen at 50 mcg/day via an implantable pump for an unknown indication for use.It was reported that the catheter tip bent and turned as visible on x-ray upon attempting to advance it.Upon removing the catheter from the needle, it was seen that the stylet had popped through one of the holes at the tip of the catheter.It was noted that the catheter may have been subdural per a dye study.A dye study was completed via another catheter kit.A new 8780 was implanted in the intrathecal space and intrathecal placement was confirmed by the hcp via another dye study.The issue was resolved and the patient's status was noted to be "alive - no injury." no further issues were reported or anticipated.

• Brand Name: ASCENDA
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8312542
• MDR Text Key: 135520805
• Report Number: 3004209178-2019-02580
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000051112
• UDI-Public: 00763000051112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2019
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 52