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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key12038999
MDR Text Key267052359
Report Number3004209178-2021-09713
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
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 Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/14/2022
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received06/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/19/2020
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
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