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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 Device Operates Differently Than Expected (2913)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Pneumonia (2011)
Event Date 05/20/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a device manufacturer representative regarding a patient receiving morphine (25 mg/ml at 2.3 mg/day) via an implantable infusion pump.The indication for use was spinal pain.It was reported that a few days ago the patient was admitted to the hospital and in the intensive care unit due to pneumonia and symptoms of a low heart rate and blood pressure.It was reported that the patient was given narcan once or twice because of their heart rate being so low.The caller stated contradictory statements that they thought the pump was malfunctioning but also that the managing hcp did not think that the patient's condition was related to the pump.It was reported that the pump was interrogated and there were no indications of any pump problem.It was noted that the last refill was on (b)(6) 2018 and the pumps reservoir contained 14ml of medication.No further complications have been reported as a result of this 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 Key7540434
MDR Text Key109127268
Report Number3004209178-2018-11734
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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 05/24/2018
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 Date04/28/2016
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 05/23/2018
Initial Date FDA Received05/24/2018
Date Device Manufactured11/06/2014
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 Outcome(s) Hospitalization; Life Threatening; Other;
Patient Age83 YR
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