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

Model Number 8637-20

Device Problems Filling Problem (1233); Increase in Pressure (1491); Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving baclofen and dilaudid via an implantable pump for non -malignant pain.Drug concentrations and dose rates of both pump medications were unknown.An issue of refilling to capacity before each session was reported.The patient had about 20 consecutive sessions, one every day until finished.The patient has had to do hyperbaric treatments for dental and had been in touch with a manufacturer representative about them.When the patient had some of these treatments before, they could hear and feel a noise and a pop or rumble.The patient thought that while under pressure the pump was compressing and expanding.They stopped the treatments and the patient found out he had very high blood pressure.Since that happened, the patient has had three refills and has heard the noise/pop or rumble again when he had his very last refill.The patient however did not hear it the other two times.The patient reported it to his healthcare provider who had contacted a company representative about it and the company representative had called the patient.Since that time, the patient has tried to reach the company representative again but has not heard back.The first time they had heard the noise and a pop or rumble was in (b)(6) or (b)(6) of 2018.The date (b)(6) 2018 is considered an approximate date of event.The second time they had heard the noise and a pop or rumble with refill was about three weeks ago in 2019 (year known only).It was noted that the company representative was made aware approximately 3 weeks ago in 2019 (approximately (b)(6) 2018).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received via a company representative.It was clarified that the company representative was only contacted after the patient spoke with the manufacturer.The patient afterwards contacted the healthcare provider (hcp) office and they advised that the patient contact the company representative.It noted that he stated they told him the number of atmospheres.After speaking with the hcp, the pump refills seemed to be consistent at 20 ccs.Regarding the cause of the issue with refilling to capacity and patient having felt/heard a noise/pop/rumble at refill, and having had high blood pressure, it was noted that the physician had the patient come in several times for the refills and to check the volume for consistency.Regarding if the issue of refilling to capacity, patient having felt/heard a noise/pop/rumble at refill, and high blood pressure had been resolved, it was noted that the high blood pressure was not known.The patient¿s weight was unknown; healthcare provider¿s office did not have the weight from the last visit.The information provided was noted as having been confirmed with the physician/account.

• 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: 8724680
• MDR Text Key: 153599902
• Report Number: 3004209178-2019-12142
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Date Device Manufactured: 02/09/2016
• 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: 61 YR