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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 Problems Particulates (1451); Device Ingredient or Reagent Problem (2910)
Patient Problem Purulent Discharge (1812)
Event Date 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient receiving compounded baclofen 750 mcg/ml at 420 mcg/day via an implantable pump.On (b)(6) 2020 the healthcare provider reported that he pulled ¿pus¿ from the patients pump reservoir.The healthcare provider stated it looked greenish and had stringy solid like particles in it.The patient was asymptomatic but has a hernia in the area of the pump.The provider said he pulled out 6.1 ml of the ¿pus¿ like fluid when 6.8ml was expected.He then did 2 saline flushes and removed what he put in, confirming in his mind that he was in the reservoir.The healthcare provider put in new baclofen medication and monitored the patient for 30 minutes and the patient remained asymptomatic.He reports the first flush still had the stringy particles in it but the second flush was clear.The provider did not save the ¿pus¿ fluid for analysis.The environmental, external or patient factors that may have led or contributed to the issue was the patient had a hernia near pump pocket that has not been treated because of covid-19 pandemic.The diagnostics and troubles shooting performed was 2 saline flushes to clean the reservoir.There were no actions and interventions taken to resolve the issue.It was unknown if the issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications regarding the event.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9976484
MDR Text Key192367466
Report Number3004209178-2020-07363
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508156
UDI-Public00643169508156
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2020
Initial Date FDA Received04/20/2020
Date Device Manufactured12/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age49 YR
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