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

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

Patient Problem Therapeutic Effects, Unexpected (2099)

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 receiving an unknown dose and concentration of morphine via an implantable pump for non-malignant pain.It was reported the patient had encountered the poor communication screen/icon on their personal therapy manager (ptm).The patient wanted to know how often they can use their ptm if they need it.The patient stated they use their ptm four-times a day but sometimes need to use it more than that.However, the patient was afraid to use the ptm more than four-times because they did not know how much was ¿in the in the ptm.¿ the patient asked patient services how they would know if their pump ran out of medication.Patient services reviewed the applicable information.Patient services attempted to walk the patient through their lockout parameters on the ptm, however the patient was encountering the poor communication screen.Troubleshooting was performed on the call in which the patient attempted to use their ptm without the antenna.It was indicated the patient wanted to try using an antenna.The patient was instructed to not move the ptm from the pump site until they heard the ptm stop beeping.The patient was instructed to push the selector key to bond the ptm to the pump.It was indicated the patient did not have an antenna.The patient stated they put the screen facing their pump.Patient services reviewed that the back of the ptm needed to be up against their skin.The patient reported they were getting the check in the box.It was reported the ptm was still not operating as expected.The patient also reported they had not noticed a difference with the boluses and did not know if they had been receiving them.The patient said they did not know because they get a steady drip of medication.The patient stated when they began their infusion therapy the doctor turned up their dose a quarter of the way, and then turned it up a little bit more when their stitches were taken out.The patient did not know when the issues began.No out of box failures were reported.No medical or therapy problems associated with a small part were reported.The patient reported they have an upcoming appointment with their healthcare provider on (b)(6) 2018.The patient was transferred to repair.Additional information was received from the consumer on march 23, 2018.The patient reported they received their new replacement ptm and they were still having the same issue communicating with their pump.The patient reported they could not bond with their pump using their ptm both with and without the antenna.Patient services reviewed what the home screen on the ptm should look like and reviewed this information with the old ptm.Patient services also reviewed what the screen should look like when the bolus is accepted.Patient services consulted with repair and redirected the patient back to their healthcare provider to check the patient¿s pump at this point.Patient services sent the patient the ptm manual.No further complications were reported or anticipated.It was also reported the patient had stage four throat cancer and was getting ready to have surgery.

• 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: 7434241
• MDR Text Key: 106145256
• Report Number: 3004209178-2018-08143
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Date Device Manufactured: 12/26/2017
• 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