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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problems Therapeutic Response, Decreased (2271); Insufficient Information (4580)
Event Date 02/26/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that in the last 2-3 months the patient had been going through withdrawals once per week. It was reported that the doctor said that since this all started the patient had congestive heart failure. It was reported that the patient was currently going through a withdrawal. It was reported that the patient was in the icu from (b)(6) to (b)(6) due to the withdrawals. The patient stated that they had to increase to 6 boluses per day because 4 boluses wasn¿t helping. The patient stated that on (b)(6) their pump was refilled, and they were locked out from then to (b)(6) with no bridge boluses. It was reported that this is when all the trouble started. The patient stated that they had to slowly increase their medication to where they originally were. The patient stated that their old pump never had problems. The patient stated that they cannot go to the er anymore. It was reported that the patient had an appointment on (b)(6) to have their pump checked. The patient stated that they hadn¿t yet checked but that they know that they were going through withdrawals. The patient stated that no one had checked it when it happened weekly due to covid-19. No further complications were reported. Additional information was received from a healthcare professional (hcp). It was reported that the model and serial numbers of the personal therapy manager (ptm) was not available and there were no known issues with the ptm. It was reported that the refill originally reported to have occurred on (b)(6) 2020 was actually performed on (b)(6) 2020. Pump reservoir volume was reported as 11 ml and the actual volume removed was 10. 7 ml. It was reported that the patient activated dose was changed from 0. 571 mg to 0. 520 mg morphine. A bridge bolus was performed. Regarding the cause of the reported congestive heart failure it was reported that the working diagnosis was acute viral cardiomyopathy. The patient did not have any pre-existing condition of congestive heart failure. The intermittent weekly withdrawal symptoms were confirmed, but no cause was determined. It was reported that the withdrawals started on (b)(6) 2020. It was reported that the lockout occurred from (b)(6) 2020 to (b)(6) 2020 and was caused from a change in morphine concentration from 17 mg/ml to 17. 5 mg/ml. As part of diagnostic testing a side port check of the catheter was performed as well as a myelogram performed using a ct scanner on (b)(6) 2020. It was reported that there was free flow of cerebral spinal fluid (csf) on the catheter. It was reported that multiple dose escalations were performed on the pump to attempt to resolve the withdrawal symptoms but they persisted. The congestive heart failure was resolved. It was reported that the patient opted for a new pump and it was replaced on (b)(6) 2020. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer on 2020-jul-06. The patient's weight was provided.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key10142614
MDR Text Key198308943
Report Number3004209178-2020-10124
Device Sequence Number1
Product Code LKK
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 Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/03/2019
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: 06/11/2020 Patient Sequence Number: 1
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