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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ZEPHYR MODEL 5626 SINGLE CHAMBER RATE MODULATED PACEMAKER

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ST. JUDE MEDICAL ZEPHYR MODEL 5626 SINGLE CHAMBER RATE MODULATED PACEMAKER Back to Search Results
Model Number 5626
Device Problems Sensor problems (1561); Device Operates Differently Than Expected (2913)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Event Date 12/10/2012
Event Type  Injury  
Event Description
Marked acceleration of the paced rate while the pt was lying quietly on the procedure table. I was asked to evaluate a pt ((b)(6)) who has a chronic sjm zephyr xl sr model 5626 sn (b)(4). He is currently an inpatient at (b)(6) medical center for unstable angina. He has chronic atrial fibrillation and generally (but not always) good control of his ventricular response to the afib. The pacing systems checks out as functioning properly. It was programmed to the vvir mode, a base rate of 75 pbm and a maximum sensor rate of 140 bpm and after the evaluation based on what i was subsequently shown, i reduced the msr 10 120 bpm. The other data was recorded during his catheterization. On monday, he underwent a diagnostic cardiac catheterization and angioplasty of his left circumflex artery. The angioplasty procedure itself was uncomplicated. However, during the procedure, his paced rate spontaneously increased to the msr at 140 pbm and with this, his bp dropped significantly. He did not suffer any adverse consequences from this but when the interventional cardiologist realized that he had a single chamber pacemaker and not a dddr system, he realized that there was no sinus tachycardia to track and throughout all of this, the pt was lying quietly on the exam table making it difficult to impact the accelerometer, he asked that i re-evaluate the pacing system. Again, the pacing system is functioning normally on today's evaluation. But i cannot explain the observed behavior. The hemodynamic recordings obtained during the catheterization have been scanned and are incorporated as well. I am aware of reports of ct scans triggering an increase in the paced rate in some pacemakers but i am not familiar with the specific details. This lab did not incorporate a ct scan. The interventional cardiologist is dr (b)(6) who spends part of his time at (b)(6) and part at (b)(6). Either he or dr (b)(6), can provide manufacturer and models of most of the equipment in the cath lab but this might be something that one of the tech service engineers would like to visit and review directly. I will leave it to you as to what needs to be done to pursue this evaluation. I would appreciate a formal report as to the results of your analysis so that it can be incorporated in the pt's chart and be available to the clinicians caring for this gentleman should unexpected behavior occur in the future with this particular pulse generator. At the moment, my plan is to continue to follow him in a routine manner. If you would like me to call him back to retrieve any specific data from the device memory, i should be pleased to do so. Should you have further questions about the device, please contact me. If you have specific questions with respect to the equipment in the cath lab and general environment, you will need to talk to either dr (b)(6). Pt underwent a successful angioplasty and placement of a drug-eluting stent. Dates of use: (b)(6) 2012 to present. Diagnosis: 2nd degree av block in the setting of chronic atrial fib.
 
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Brand NameZEPHYR MODEL 5626
Type of DeviceSINGLE CHAMBER RATE MODULATED PACEMAKER
Manufacturer (Section D)
ST. JUDE MEDICAL
15900 valley view court
sylmar CA 91342
MDR Report Key2887567
MDR Text Key3060859
Report NumberMW5028298
Device Sequence Number1
Product Code NVZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/12/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2012
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number5626
Device Lot NumberINDIVIDUAL ITEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Unknown
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/19/2012 Patient Sequence Number: 1
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