MEDTRONIC, INC. VISIA AF MRI¿ VR SURESCAN¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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Model Number DVFB1D4 |
Device Problems
Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
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Patient Problems
Cardiac Arrest (1762); Fall (1848); Failure of Implant (1924); Ischemia (1942); Tachycardia (2095); Ventricular Fibrillation (2130)
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Event Date 04/28/2022 |
Event Type
Injury
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Event Description
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Received notification that patient had an implantable cardioverter defibrillator (icd) placed which appeared to not work as it should when patient went into cardiac arrest.The patient was resuscitated by bystanders, and an automated external defibrillator (aed).The icd was sent to the company, and the company returned a report back to the cardiologist indicating the icd malfunctioned.Patient's right ventricular lead was extracted.Patient's right ventricular rv lead was extracted.A df-1 dual-coil icd lead was implanted.Per patient's discharge summary: patient presented as a transfer after having 12 unsuccessful icd shocks.The first episode lasted about 4 minutes with 2 bursts of antitachycardia pacing (atp) and 6 shocks (36j, 36j, 3.6j, and 3 shocks with 0j energy).The second episode lasted about 2 minutes and he had 6 shocks with 0j of energy delivered.Ultimately patient collapsed in a parking lot and received bystander cardiopulmonary resuscitation (cpr) and shocks from an aed, and ultimately achieving return of spontaneous circulation (rosc).Patient was never intubated and remained stable after that point.Given these shocks, patient was transferred for further management.On arrival, patient appeared stable and did not have any recurrent arrhythmia.On interrogation, it was revealed that patient's rv lead impedance had decreased significantly, giving concern to an insulation breach of the rv lead.Patient ultimately underwent rv lead explanation, dual chamber icd implantation and higher voltage can on 5/4 with his provider.His initial event was thought to be due to coronary vasospasm leading to ischemia and ventricular fibrillation arrest.His antianginals were up titrated and he was discharged.
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Event Description
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Received notification that patient had an implantable cardioverter defibrillator (icd) placed which appeared to not work as it should when patient went into cardiac arrest.The patient was resuscitated by bystanders, and an automated external defibrillator (aed).The icd was sent to the company, and the company returned a report back to the cardiologist indicating the icd malfunctioned.Patient's right ventricular lead was extracted.Patient's right ventricular rv lead was extracted.A df-1 dual-coil icd lead was implanted.Per patient's discharge summary: patient presented as a transfer after having 12 unsuccessful icd shocks.The first episode lasted about 4 minutes with 2 bursts of antitachycardia pacing (atp) and 6 shocks (36j, 36j, 3.6j, and 3 shocks with 0j energy).The second episode lasted about 2 minutes and he had 6 shocks with 0j of energy delivered.Ultimately patient collapsed in a parking lot and received bystander cardiopulmonary resuscitation (cpr) and shocks from an aed, and ultimately achieving return of spontaneous circulation (rosc).Patient was never intubated and remained stable after that point.Given these shocks, patient was transferred for further management.On arrival, patient appeared stable and did not have any recurrent arrhythmia.On interrogation, it was revealed that patient's rv lead impedance had decreased significantly, giving concern to an insulation breach of the rv lead.Patient ultimately underwent rv lead explanation, dual chamber icd implantation and higher voltage with his provider.His initial event was thought to be due to coronary vasospasm leading to ischemia and ventricular fibrillation arrest.His antianginals were up titrated and he was discharged.
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