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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Excess Flow or Over-Infusion (1311); Improper Flow or Infusion (2954)
Patient Problems Pain (1994); Cognitive Changes (2551); Insufficient Information (4580)
Event Date 02/10/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving morphine (40 mg/ml at 8 mg/day) via an implantable pump. It was reported that the patient's pump was refilled on (b)(6) 2022 and the following day, the patient was in intensive care unit because of overdose symptoms. Factors that may have led or contributed to the issue was noted as being not applicable. The healthcare provider who performed the refill was sure they didn't refill the pump pocket. The pump was first put in a minimal rate. The patient was reactive. The pump was emptied on (b)(6) 2022 and there was 10 ml removed instead of approximately 10 ml. The healthcare provider decided to shut down the pump (definitive) and to deal with the patient symptoms with other treatments. The healthcare provider was informed that the pump would not be able to work again and that the overdose / withdrawal symptoms had to be taken in charge. The issue was not resolved as of (b)(6) 2022. The pump remained implanted and out of service. No surgical intervention occurred and it was unknown if surgical intervention was planned. The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13537258
MDR Text Key288381493
Report Number2182207-2022-00261
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/15/2022 Patient Sequence Number: 1
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