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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 Insufficient Flow or Under Infusion (2182)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Coma (2417)
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) via company representative (rep) regarding a patient who was receiving baclofen (unknown concentration or dose) via implantable infusion pump. It was reported that the patient became spontaneously comatose with low blood pressure and heart rate in the 40s. Extensive work-up revealed no cardiac or pulmonary abnormalities. There was no evidence of infection. The patient was treated with hydration and intubation was on-deck when the patient improved several hours later. The icu team diagnosed the patient with baclofen pump toxicity and the pump was replaced without incident with a flowonix pump. The catheter was drained normally. The pump was assessed in the icu and was found to have residual volume slightly higher than expected volume. No side port was done due to concern about reliability of prime bolus given possible pump over-infusion. The factors that may have led or contributed to the issue were unknown. The issue was resolved at the time of report. The patient's weight and medical history were asked and will not be made available. The patient's status at the time of report was alive - no injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Destructive analysis identified residue in the motor gear train. Analysis identified wearing on the upper shaft of gear number two. 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 Key13153599
MDR Text Key283168606
Report Number3004209178-2022-00050
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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: 01/04/2022 Patient Sequence Number: 1
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