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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

Patient Problems Abdominal Pain (1685); Diaphoresis (2452); Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received via an email from the patient who was receiving an bupivacaine and dilaudid via an implanted pain pump.The patient reported that his pump had an alarm going off.Per the patient he currently lived in (b)(6) and previously lived in (b)(6).He called the company representative he had in (b)(6) who told him it was time for his pump to be replaced.His pain management doctor¿s staff said it would not be alarming if it were working properly.The patient was wondering if a local representative could speak with his pain management doctor on his behalf.Additional information received from a patient reported for the past 3 weeks to a month, the patient has been feeling really bad and like going through withdrawals because the pump was not working.It was mentioned that when this started happening they ended up in the er because the patient woke up drenched in sweat and stomach was achy.The patient stated the pump has been also beeping intermittently as well and was told on monday at the pump refill when the pump was beeping, that the pump was stalling out.It was stated every time the pump beeps it is a single tone beep.The patient stated the pump is due to be replaced since it has been 7 years and they saw a code of 84 something.The patient was redirected to their managing hcp.It was stated the medication dose for dilaudid (hydromorphone) is maybe like 0.2.Troubleshooting was not required.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11880878
• MDR Text Key: 267150560
• Report Number: 3004209178-2021-08306
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/25/2021

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?: 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
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/25/2021
• Date Device Manufactured: 03/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Age: 52 YR