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

Model Number 8637-20

Device Problem Mechanical Jam (2983)

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

Event Date 12/01/2017

Event Type  malfunction  

Event Description

Information was received from a consumer on (b)(6) 2017 regarding a patient receiving dilaudid (dose and concentration unknown) via an implanted infusion pump.The indication for use was spinal pain.It was reported that the patient underwent magnetic resonance imaging on (b)(6) 2017 and saw his healthcare provider (hcp) about 10 minutes later to have the pump checked.The pump was reportedly beeping in the patient's ear and the hcp told him that the pump malfunctioned and shut down.The hcp reportedly said that it may come back, but he tried to reprogram it and said "no it failed." it was noted that the pump seized and most likely the unit was damaged and broken, and the patient would need to have it replaced.The hcp also reportedly told the patient that he would most likely go into withdrawal because of this.The hcp reportedly told the patient that there was nothing he could do, and he needed to contact the manufacturer.The patient reportedly had a "busted pump" and was freaking out.It was noted that the patient had nothing but problems with the pump and was disappointed with the support for the pump.The patient's managing hcp would not be treating the patient for withdrawal because he was moving practice, and the patient was looking for a new hcp to manage and replace the pump.The patient was reportedly going to see his primary care hcp, but it was noted that they would not give him narcotics or pain meds.No further complications were reported or anticipated.

• 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: 7131362
• MDR Text Key: 95850217
• Report Number: 3004209178-2017-26304
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Date Device Manufactured: 04/05/2014
• 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
• Patient Age: 45 YR