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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD

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ST. JUDE MEDICAL ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD Back to Search Results
Model Number ICD 2207-36
Event Date 10/25/2009
Event Type  Death  
Event Description

It is not known with 100% certainty that the icd lead wire puncturing the heart was due to product defect or design or if it was a procedural issue as no autopsy was performed. However, it is our family's belief that the heart puncture and delay of care afterwards certainly contributed to contraction of pneumonia and his subsequent death. The events are as follows: on (b) (6) 2009: he had st jude implantable cardioverter - defibrillator (brand name 'current rf-dr') surgery at a (b) (4) hospital without apparent complication. On (b) (6) 2009: he was released from the aforementioned hospital. He began to complain of being "shocked" below the heart on the left side at the rib area. After multiple visits to cardiologists within one week's time, the technician said his icd did not "go off" meaning it did not indicate that it had delivered a shock his heart. On (b) (6) - (b) (6) 2010: he went to a local emergency room complaining of "being shocked" and "severe chest pain". He was discharged home each visit. On (b) (6) 2009: he returned to original hospital where it was determined that the lead wire to the icd had punctured his left ventricle and was shorting-out at his rib. On (b) (6) 2009: he had surgery to reposition the lead wire. On (b) (6) 2009: he was released from the hospital. On (b) (6) 2009: he called his primary care doctor with the complaint of labored breathing. He was sent to local hospital for chest x-ray and blood work. On (b) (6) 2009: primary doctor suspects "touch of pneumonia". On (b) (6) 2009: he is admitted to local hospital and was treated for pneumonia. On (b) (6) 2009: he dies at hospital from cardiac arrest secondary to pneumonia and electrolyte imbalance. Believed to be a single-use device and therefore e9 section believed to be not applicable.

 
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Brand NameST. JUDE MEDICAL ICD 'CURRENT RF-DR'
Type of DeviceIMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD
Manufacturer (Section F)
ST. JUDE MEDICAL
one lillehei plaza
st. paul MN 55117
Manufacturer (Section D)
ST. JUDE MEDICAL
one lillehei plaza
st. paul MN 55117
Device Event Key1750991
MDR Report Key1702683
Event Key1609244
Report NumberMW5016115
Device Sequence Number1
Product CodeLWS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2010
3 DeviceS WERE Involved in the Event:1 2 3 
1 Patient Was Involved in the Event
Date FDA Received05/18/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberICD 2207-36
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 05/18/2010 Patient Sequence Number: 1
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