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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling/ Edema (4577)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving morphine via an implanted pump. The indication for pump use was non-malignant pain. The reporter was calling to ask if the synchomed ii pump materials had changed in (b)(6) 2020. Per the reporter, the patient had a pump replacement on (b)(6) 2020. At that time the hcp wanted to switch the medication to morphine to be ¿on-label¿ to minimize the risk for stall. Since (b)(6) 2020, the patient had had a rash over his pump site with swelling. The patient went to the dermatologist who recommended getting the pump explanted because the dermatologist believed he was allergic to the pump materials. The patient had had pumps prior and never had this issue and that was why they were wondering if there was a material change. It was reviewed that there was not a material change. It was unknown if the rash was present at all times or only post-refill. The plan was to investigate further about the drug change and if the patient could be allergic to morphine. Additional information was received on 15-apr-2021 at which time it was reported that the patient¿s prior pump contained morphine and bupivacaine. The bupivacaine was removed so the current pump only had morphine in it. Additional information was received on 20-apr-2021 from the hcp via the company representative who reported that the cause for the rash and swelling over the pump site was unknown. It was unknown if the rash was present at all times or only post-refill. Per the physician, the actions and interventions taken to resolve the issue was that the refill was done without problems and they would give it one month for the allergic response to be treated. If no response, they would have to change pump. Additional information was received on 11-jun-2021 from the hcp via the company representative who reported that today they ended up replacing the pump and repositioning the new pump because of the rash over the pump site continuing. Per the reporter, they had been using a cream over the pump site to attempt to mitigate the rash, however, it did not work. The hcp had discussed explanting the pump completely with the patient and the patient and his wife stated that ¿they cannot go back to the way life was before the pump¿ and that the therapy had helped the patient tremendously. It was unknown if the pharmacy who created the medication changed any time from (b)(6) 2020 to today. Per the reporter, the hospital made the 20 mg/ml morphine solution on (b)(6) 2020 and the patient had only had one refill since. The patient¿s current dose was 3. 5 mg/day. The reporter believed that the patient was at 4. 0 mg/day, but they had titrated him down for the replacement/repositioning.

• 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: 12038999
• MDR Text Key: 267052359
• Report Number: 3004209178-2021-09713
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/14/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/22/2021 Patient Sequence Number: 1