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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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OSCOR INC EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 3401
Device Problems Failure to Convert Rhythm (1540); Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Low impedance (2285); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2023
Event Type  Injury  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
It was reported that during a change out procedure for normal battery depletion, after the new subcutaneous implantable cardioverter defibrillator (s-icd) was implanted and the shock test was performed there was non-conversion of induced ventricular tachycardia (vt).Another charge was given and there was no signal on the electrogram (egm).An external shock was given to the patient.The shock impedance was at 10 ohms and the device was unable to charge for another shock.The physician opted to explant the existing electrode and implant a new s-icd and electrode.It was noted that the electrode had been repositioned during the procedure due to concern over future perforation.There was also concern over a shock into a shorted condition.Visual inspection of the s-icd and electrode did not reveal any findings.The attempted s-icd and chronic electrode were taken out of the patient and a new s-icd system was successfully implanted.No additional adverse patient effects were reported.
 
Event Description
It was reported that during a change out procedure for normal battery depletion, after the new subcutaneous implantable cardioverter defibrillator (s-icd) was implanted and the shock test was performed there was non-conversion of induced ventricular tachycardia (vt).Another charge was given and there was no signal on the electrogram (egm).An external shock was given to the patient.The shock impedance was at 10 ohms and the device was unable to charge for another shock.The physician opted to explant the existing electrode and implant a new s-icd and electrode.It was noted that the electrode had been repositioned during the procedure due to concern over future perforation.There was also concern over a shock into a shorted condition.Visual inspection of the s-icd and electrode did not reveal any findings.The attempted s-icd and chronic electrode were taken out of the patient and a new s-icd system was successfully implanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.It was reported that the complete electrode was returned intact.Visual inspection noted cuts in the insultation at approximately 100 mm from the terminal end which was determined to be damaged during the revision procedure.The lead did not pass electrical testing.An x-ray was taken which showed the high voltage cable conductor was fracture at approximately 100 mm from the terminal end.This was determined to be due to the insulation being punctured during the revision procedure.Analysis determined that the difficulty converting rhythm, failure to sense, shock impedance low out of range, and failure to shock or properly shock issues noted in the field were confirmed and determined to be due to the fractured high voltage cable.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
OSCOR INC
3816 desoto blvd.
palm harbor FL 34683
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16891173
MDR Text Key314800506
Report Number2124215-2023-22386
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110042/S043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/01/2019
Device Model Number3401
Device Catalogue Number3401
Device Lot NumberA141480
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received05/08/2023
Supplement Dates Manufacturer Received07/20/2023
Supplement Dates FDA Received07/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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