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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ALLURE QUADRA IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3242
Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Operates Differently Than Expected (2913)
Patient Problems Syncope (1610); Dizziness (2194)
Event Date 10/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The reported field events of a set screw anomaly and noise were confirmed in the laboratory. Visual inspection identified excess epoxy in the rv ring contact spring. Lead insertion through the spring and movement of the lead and spring broke through the epoxy causing intermittent contact between the spring, ring slot, and the lead. This is consistent with the observation from the field of noise. The cause of the epoxy contaminating the ring contact spring is a manufacturing anomaly.
 
Event Description
It was reported that a pacemaker dependent patient was called in clinic due to noise observed on the rv lead. Patient was experiencing dizziness and syncope. The patient was recently upgraded to bi-v system and there was no noise prior to the upgrade. Set-screw issue was suspected. Noise was being oversensed and inhibiting the pacing. During procedure, no indication of set screw issue was noted. The lead was reconnected but still there was no clear indication of cause of noise. Lead was replaced but the noise was still evident. Device was also replaced and there was no noise issue with the new device. Physician suspected there is an issue with the device header. Patient¿s condition was stable.
 
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Brand NameALLURE QUADRA
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6232077
MDR Text Key64127298
Report Number2938836-2017-01607
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM3242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2015
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: 01/08/2017 Patient Sequence Number: 1
Treatment
(B)(4)
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