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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fatigue (1849); Overdose (1988); Pain (1994); Therapeutic Effects, Unexpected (2099); Underdose (2542)

Event Date 06/01/2017

Event Type  Injury  

Event Description

Information was received from a consumer (patient¿s family member) regarding a patient with an implantable drug infusing pump indicated for spinal pain.The pump contained fentanyl and then an unknown brand of morphine, both with unknown concentrations and doses.It was reported last week, the patient originally had fentanyl in the pain pump, but he had issues.The consumer clarified that the issues were when he first was on fentanyl, he was fine.The patient would go to the doctor to ¿up the medication¿ and adjust the bolus, but the patient got to a point where he was sleeping all day, so she thought he was getting too much pain medicine.The patient was getting short of breath to the point where he wasn¿t getting enough air.The consumer said that they went to the emergency room, and they got the pump to the point where it was too low, and it wasn¿t helping him with his neck pain.The consumer said that the patient was sleepy, so a nurse changed the pump to morphine at the hospital, and they disabled his bolus (a week ago on (b)(6) 2017).The issue first occurred ¿4 months after implant¿.The consumer was calling because the patient¿s personal therapy manager (ptm) had an out-of-box screen on it that started on (b)(6) 2017.The consumer reported that she called the doctor regarding the out-of-box screen that she was seeing thinking that ¿maybe they did not activate the ptm¿.The doctor didn¿t know what it was and suggested the consumer to call the manufacturer.The consumer reported that she saw the poor communication screen/icon on (b)(6) 2017.Troubleshooting done on the call included the consumer pushed the selector key to bond the ptm to the pump.The consumer confirmed she was using the antenna for the ptm.The consumer successfully bonded the ptm to the pump.The consumer confirmed that she could see the refill date after bonding the ptm to the pump.The consumer also did a bolus while on the phone and confirmed it was successful.There was no out-of-box failure reported.There was no medical or therapy problem associated with small parts.Troubleshooting resolved the reported issue.There were no patient symptoms at the time of the call.No further patient complications were reported.

• 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: 6952048
• MDR Text Key: 89413425
• Report Number: 3004209178-2017-21865
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• 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: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 10/16/2017
• Date Device Manufactured: 01/09/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 71 YR