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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. STREAMLINE¿; ELECTRODE, PACEMAKER, TEMPORARY
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MEDTRONIC, INC. STREAMLINE¿; ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6495F
Patient Problems Cardiac Arrest (1762); Failure of Implant (1924); Loss of consciousness (2418); Asystole (4442)
Event Date 11/16/2023
Event Type  Injury  
Event Description
Patient had undergone a redo sternotomy, aortic valve replacement (avr) (tissue), aortic root replacement, aorto-atrial fistula repair, coronary artery bypass graft surgery (cabgx1), tricuspid valve debridement, and was noted by physician as doing well.The sternal dressing is to be changed 24 hrs.Post-op per physician orders.An registered nurse (rn) was taking off the saturated sternal dressing and noted there was low visibility of the pacer wire, during the dressing change, the patient became unresponsive and was asystole.A code was called, and cardio-pulmonary resuscitation (cpr) was initiated.The physician was in the next room and immediately responded to cpr.Return of spontaneous circulation (rosc) achieved after two minutes of cpr and 1 of epinephrine.It was noted after rosc it was found that sternal pacer wires that were placed the day prior were severed/discontinuous.Sternal wires were found to be in between gauze and tape on sternal dressing.Patient was pacemaker dependent.External pacing pads placed, patient intubated and taken to cath lab for temporary pacer placement in the right groin.
 
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Brand Name
STREAMLINE¿
Type of Device
ELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key18667537
MDR Text Key334898497
Report Number18667537
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2023
1 Device was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number6495F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2023
Event Location Hospital
Date Report to Manufacturer02/08/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
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