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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Dehydration (1807); Numbness (2415); Sleep Dysfunction (2517)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient receiving dilaudid (at an unknown concentration at 7.002 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that the patient was running out of medication ((b)(6) 2019 was the date given as date the pump would be empty) but the patient had moved and was having difficulty getting the pump filled.It was noted that the patient was going crazy due to not using his boluses for pain to try and extend the refill date.No further complications have been reported as a result of this event.Additional information was received from a consumer.The patient has not been able to find anyone to fill the pump.The alarm date was (b)(6) 2019.The patient had cut down on bolus's but did have 6 the other day.On (b)(6) 2019 the patient was feeling nauseous and threw up.The pain was getting worse since the patient was not using the bolus.The patient¿s heart rate and blood pressure are up.The patient contacted the doctor but has not received a response.The patient could not get in to see their primary doctor until (b)(6) and then he will send a referral for a pump doctor.Additional information was received from a consumer on (b)(6) 2019.It was reported that the patient's pump began alarming on thursday, (b)(6) 2019, and the patient began "feeling really bad on friday" so he went to the emergency room (er) where he was provided with three days of oral medication.However, he was redirected to get his pump filled and was told to not come back to the er as they were unable to help him and he would "not die from these symptoms." he had tried calling the names on the listings provided to him but no one was able to fill his pump.He reported symptoms of back pain, shaking and high blood pressure.No further complications were reported.Additional information was received from the consumer indicated the patient's pump had gone empty (patient initially reported (b)(6) 2021 but later in the call stated it went empty in (b)(6) 2021) due to their healthcare provide (hcp) not being close.The caller stated that they had been going through withdrawals and had to be hospitalized.The patient was in the hospital for 5 days; his heart rate was really high, wasn't able to sleep, dehydrated, depressed, unable to eat, numbness of leg and a lot of pain.The hospital gave him some oral dilaudid for 3 days ((b)(6) 2021) and the managing hcp gave him about 16 days of oxycodone to help back on (b)(6) 2021.Because the patient was having such a hard time having his pump refilled, he would rather have the pump explanted and re-implanted by another hcp.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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13357700
• MDR Text Key: 289202783
• Report Number: 3004209178-2022-01188
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2022

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: 07/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 01/26/2022
• Date Device Manufactured: 02/12/2018
• 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): Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 64 KG