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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 Electromagnetic Interference (1194); Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen with concentration 2000 mcg/ml at a dose rate of 376,1 mcg/day (flex dose rate) via an implantable pump. It was reported that the patient was hearing three times beeping of her pump every ten minutes. On (b)(6) 2020 another specialized nurse visited the patient for checkup and to read the pump logs. As per the logs a critical alarm regarding motor stall occurred on (b)(6) 2022 at 18:36 followed by a motor stall recovery on (b)(6) 2022 at 19:06. Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient drove in a taxi van with no iphone, and with the belt positioned on the wheelchair (not on their belly). During phone call, and after another an hour of contact, nothing more was to be heard. The patient did not experience any complaints; therefore, no further actions were taken. No catheter issue was observed. No surgical intervention occurred and no surgical intervention was planned. The issue was resolved as of (b)(6) 2022. The patient was without injury regarding their status as of (b)(6) 2022. The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.
 
Manufacturer Narrative
Concomitant medical products: product id: 8731sc, lot#: unknown, product type: catheter. The date (b)(6) 2022 is considered an approximate date of implant (specific month and year known only). 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 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 Key14215064
MDR Text Key290575280
Report Number3004209178-2022-05278
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeNL
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 Nurse Practitioner
Type of Report Initial,Followup
Report Date 05/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/20/2021
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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