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

Model Number 8637-20

Device Problem Data Problem (3196)

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

Event Date 02/12/2020

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 manufacture representative regarding a patient receiving gablofen (500 mcg/ml at 154.7 mcg/day) via an implanted pump.It was reported the patient's pump was being updated and they got a message stating there was a pump memory error.Tech services advised the caller to check all setting in the programmer for accuracy and update the pump again.No symptoms/patient complications were reported and troubleshooting resolved the issue.Additional information received from a healthcare provider reported the programmer was a (b)(6) tablet.There was no cause of the pump memory error and the patient's weight was (b)(6) kilos.

• Brand Name: SYNCHROMED II
• 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: 9780941
• MDR Text Key: 186729863
• Report Number: 3004209178-2020-04514
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/03/2020
• Date Device Manufactured: 12/12/2019
• 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: 14 YR
• Patient Weight: 33