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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 8637-40
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
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 w as receiving baclofen (500. 0 mcg/ml at 33. 03 mcg/ml) via an implantable pump. It was reported that the patient's pump stopped and alarming without reason. As per the logs provided the following occurred: (b)(6) 2021 17:36 critical alarm: pump motor stall, (b)(6) 2021 19:21 pump motor stall. Recovery, (b)(6) 2022 8:03 critical alarm: pump motor stall, (b)(6) 2022 11:08 pump motor stall. Recovery, (b)(6) 2022 14:00 critical alarm: pump motor stall, (b)(6) 2022 16:01 pump motor stall. Recovery, (b)(6) 2022 20:00 critical alarm: pump motor stall, (b)(6) 2022 21:06 pump motor stall. Recovery, (b)(6) 2022 20:15 critical alarm: pump motor stall, (b)(6) 2022 20:45 pump motor stall. Recovery, (b)(6) 2022 13:58 critical alarm: pump motor stall, and (b)(6) 2022 15:04 pump motor stall. Recovery. Environmental/external/patient factors that may have led or contributed to the issue was unknown.   actions taken to resolve the event as of (b)(6) 2022 were unknown.   it was unknown if surgical intervention was to occur.   the patient was without injury regarding their status as of (b)(6) 2022.   the issue was not resolved as of (b)(6) 2022. The patient's gender, medical history, age, and weight at the time of the event were unknown or would not be made available.
 
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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 Key14220234
MDR Text Key290799827
Report Number3004209178-2022-05323
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFI
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
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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