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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 RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problem Misconnection (1399)
Patient Problem Dizziness (2194)
Event Date 10/12/2018
Event Type  Injury  
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 to the emergency room with dizziness. Upon interrogation of the pulse generator, multiple episodes of right ventricular lead noise resulting in inhibited pacing was noted. Provocative testing and header manipulation showed lead noise. The device was reprogrammed. The lead was capped and the device was explanted (b)(6) 2018; both were replaced. The patient was stable.
 
Manufacturer Narrative
The reported field event of rv lead noise resulting in inhibition of pacing was not confirmed in the laboratory. The device was tested on the bench and no anomalies were found.
 
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Brand NameQUADRA ALLURE MP RF 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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8011809
MDR Text Key125271269
Report Number2017865-2018-16035
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P910023
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 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model NumberPM3262
Device Lot NumberA000010840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/28/2018 Patient Sequence Number: 1
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