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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ALLURE CRT-P PACEMAKER

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ST. JUDE MEDICAL, INC. QUADRA ALLURE CRT-P PACEMAKER Back to Search Results
Model Number PM3542
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  malfunction  
Event Description
During an implant procedure and before the pocket closure, it was discovered that the right ventricular (rv) lead was dislodged. It was impossible to disconnect the rv lead from the header of the pacemaker. In order to resolve the event, both the rv lead and the pacemaker were replaced. Additional information was requested but is yet to be provided. The patient was stable. Related mfr # is: 2938836-2018-12288.
 
Manufacturer Narrative
The reported event of the rv-lead was stuck could not be untightened from the header was confirmed. The analysis found the rv-setscrew was firmly stuck in the connector block and required destructive methods to separate it from the device connector. Analysis performed using scanning electron microscope confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrew to get stuck. When the setscrew was tightened on the leads during the implant procedure the epoxy in the threads caused in the setscrew to be locked in place which prevented removal of the lead. A manufacturing anomaly may have occurred that left or caused the epoxy to be in the connector block threads. As a result of these findings, abbott is performing further investigation. No electrical anomalies were found. The battery voltage is above eri near bol.
 
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Brand NameQUADRA ALLURE CRT-P
Type of DevicePACEMAKER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8094297
MDR Text Key128265259
Report Number2017865-2018-17315
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberPM3542
Device Lot NumberA000054310
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 Received01/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2018
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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