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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 Failure To Service (1563); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
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 consumer and healthcare provider via a company representative regarding a patient who was receiving a baclofen with concentration 250 mcg/ml at a flex dose rate of 30. 51 mcg/day via an implantable pump for intractable spasticity and multiple sclerosis. The drug lot number of baclofen was unable to be obtained. As per the pump log provided the pump administered lioresal as of (b)(6) 2017. The patient¿s medical history included multiple sclerosis. It was reported that the patient¿s pump was empty. The event occurred during normal use. Environmental/external/patient factors that may have led or contributed to the issue was noted as being non-compliance. The patient had presented to a physician¿s clinic on (b)(6) 2018 because the pump volume was depleted. The pump was stated as having been beeping / alarming for about a week. The patient had been released from their previous managing physician and the patient didn't know why; however, a prior clinic stated non-compliant with refill appointments. According to the event log, the low reservoir alarm (lra) occurred (b)(6) 2018 and the empty reservoir alarm occurred (b)(6) 2018. The patient was being maintained on oral baclofen; the dosage was unknown dosage. The issue was unresolved at the time of the report. The physician planned to refill the pump next week. The company representative planned to follow up when all information was gathered after refill. The patient was without injury at the time of the report. No patient symptom was reported. No further patient complications have been reported as a result of this event. The patient¿s medical history included: multiple sclerosis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a company representative. The cause of the patient¿s pump having been empty was confirmed as having been due to patient non-compliance. A refill was performed on (b)(6) 2018. It was unknown if the patient experienced any symptoms related to the empty pump. The issue was resolved.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7580053
MDR Text Key110458636
Report Number3004209178-2018-12908
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/31/2017
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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