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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 Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, patient's family, foreign) regarding a patient who was receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump for unknown indications for use. It was reported that on (b)(6) 2022, the 400 hotline received a notification from manufacturer staff on wechat that on (b)(6) 2022 after returning to the hospital to program control dosing, the pump showed a prompt that the motor stalled. There were no expert opinions. It was noted that effective measures had been taken. Troubleshooting performed including dates and results were unknown. Regarding explant date of the pump, it was noted that this was not applicable. The patient's age was unknown.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 MN 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13829847
MDR Text Key287885590
Report Number2182207-2022-00456
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/22/2019
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: 03/20/2022 Patient Sequence Number: 1
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