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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problems Difficult to Interrogate (1331); Incorrect Measurement (1383); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2019
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the patient presented for an unrelated procedure. During the procedure it was noted that it took hours to interrogation the patient's pacemaker and an abnormal battery longevity was calculated. On (b)(6) 2019, the device was reinterrogated and slow interrogation and an abnormal battery longevity were calculated again. In addition, it was noted that an electrocardiogram display issue was also observed. No intervention was performed and no adverse patient consequences were reported.
 
Event Description
New information noted that the slow interrogation was a result of radio frequency lockout and that the electrocardiogram display issue was a consequence of the slow telemetry. In addition, the calculated abnormal battery longevity was determined to be appropriate and within range given the age of implant of the patient's pacemaker along with it's programmed settings.
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
MDR Report Key9508923
MDR Text Key174363333
Report Number2017865-2019-18324
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000083868
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2019
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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