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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3371-40QC
Device Problems Break (1069); Migration (4003)
Patient Problem Twiddlers Syndrome (2114)
Event Date 11/28/2019
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
Related manufacturer reference number: 2938836-2019-17121; 2938836-2019-17122.It was reported that when the patient presented for follow up in clinic, high thresholds were noted at right ventricular(rv) and left ventricular(lv) lead.X-ray exhibited dislodgement for both rv and lv lead and device was found to be flipped in pocket with leads braided next to the device.The dislodgement was found to be due to twiddler syndrome.The device was disabled.The patient presented after few days on 09 december for lead revision.Twiddler syndrome was confirmed after opening the pocket.The rv lead was found to be braided multiple times after opening the pocket.But no visible damage was noted.The rv lead was explanted and replaced.The lv lead remained implanted with no repositioning or replacement as the thresholds were acceptable.All the leads were connected to the existing device with all the parameters within normal limit.The patient was stable before, during and after the procedure.
 
Event Description
New information received notes that the left ventricular lead (lv) was also damaged.The device damage was noted due to the twiddler syndrome.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9485150
MDR Text Key173358249
Report Number2938836-2019-17164
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Model NumberCD3371-40QC
Device Lot NumberS000061340
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DURATA STS; QUARTET
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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