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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 High impedance (1291); Failure to Interrogate (1332); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
Event Type  malfunction  
Event Description
It was reported that during initial implant procedure, the patient's new implanted pacemaker exhibited high, out of range pacing impedance.It was also found that the lead was not able to completely connect into pacemaker header and was not able to connect to the programmer.The pacemaker was not implanted during procedure on (b)(6) 2022.An alternate pacemaker was installed.There were no patient consequences.
 
Event Description
It was reported that during initial implant procedure, the patient's new implanted pacemaker exhibited high, out of range pacing impedance.It was also found that the lead was not able to completely connect into pacemaker header and was not able to connect to the programmer.The pacemaker was not implanted during procedure on (b)(6) 2022.An alternate pacemaker was installed.There were no patient consequences.
 
Manufacturer Narrative
The complaints of failure to interrogate and high pacing impedance were not confirmed.As received, the device was returned with battery voltage above elective replacement indicator level.Telemetry test, pacer lead impedance test, longevity analysis, header and connector analysis was normal with no anomalies found.
 
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Brand Name
QUADRA ALLURE MP CRT-P
Type of Device
IMPLANTABLE 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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key13524447
MDR Text Key285551195
Report Number2017865-2022-03120
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000126762
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
QUARTET; TENDRIL; TENDRIL
Patient Age81 YR
Patient SexFemale
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