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

Model Number 8637-20

Device Problem Computer Software Problem (1112)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial#: unknown, product type: programmer, physician, product id: a810, product type: software, product id: 8870bbu01, serial#: unknown, product type: software.Other relevant device(s) are: product id: 8840, serial/lot #: unknown, product id: 8870bbu01, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen 2000 mcg/ml at a dose of 262.8 mcg/day via an implantable pump.The indication for use was not provided.It was reported that while using the a810 software (version 1.1.300), they were able to interrogate the pump normally but when they tried to retrieve the logs the screen of the tablet went black and the application closed down.They also tried using the 8870 software, but the ¿broken card¿ screen was shown and after re-trying no logs were listed.It was noted that the patient went for an mri scan and the hcp indicated they had the same interrogation problem before and after the scan.The patient was not showing any symptoms and the pump seemed to be working as intended.The interrogation report (without logs) from the a810 programmer interrogation was provided.It was indicated that they did not have a report from the interrogation with the 8870 programmer software.

Manufacturer Narrative

Product id 8840, serial# (b)(4).Product type programmer, physician, product id 8840, serial# (b)(4).Product type programmer, physician, product id a810.Product type software, product id 8870bbu01, serial# unknown.Product type software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received confirmed that the reported "broken card" screen that was seen on two clinician programmers was the hardware/software failure message that shows a broken programmer.

• 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: 9547303
• MDR Text Key: 176303105
• Report Number: 3004209178-2020-00144
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• Date Device Manufactured: 03/22/2014
• 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