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

Model Number 8637-20

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received from a patient who was receiving hydromorphone (10 mg/ml) via an implantable pump for non-malignant pain.It was reported that the patient wanted the mdt representative's (rep) phone number because their pump had gone "empty" and they were having withdrawal symptoms.They stated they had a new pain clinic due to insurance reasons but they were unable to provide a specific physician name.They stated the nurse at that clinic suggested the patient go to the emergency room and get the pump filled with saline.Agent reviewed mdt rep role and redirected to healthcare provider's (hcp).Agent tried to clarify event date but the patient did not provide clear information.They stated about 2 weeks ago they heard the pump alarming inside their head but other people confirmed they could hear the alarm for about a week.They mentioned their pump medication would last about 2 months/about a month and 3 weeks.The issue was not resolved as troubleshooting is not needed.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13043588
• MDR Text Key: 282501012
• Report Number: 3004209178-2021-18786
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2021
• Date Device Manufactured: 05/23/2017
• 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 Sex: Female