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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. HELIOS, 5F UN-SHROUDED ELECTRODE, PACEMAKER, TEMPORARY

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OSCOR INC. HELIOS, 5F UN-SHROUDED ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number H05110U
Device Problem Pacing Problem
Event Date 05/10/2019
Event Type  Malfunction  
Manufacturer Narrative

Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.

 
Event Description

The customer reported there was an alleged material-related incident during a cardiac intervention (tf tavi) with an oscor flow directed pacemaker lead. After consultation with the user (senior physician of the anesthesia), we can describe the procedure as follows: before the intervention, during the initiation phase, the oscor helios temporary pacemaker lead was washed as regular and positioned. It achieved perfect function and a threshold of 0. 5 v after positioning. During the routine check, prior to the planned rapid pacing, all of a sudden there was no longer a signal. Due to several attempts of troubleshooting (including changing the transfer cable, and changing the pacemaker unit) there was approximately a 20 minute procedure delay. The pacing lead was exchanged with a competitors lead, and the unit was used to ensure the functionality again and continued the intervention. The customer does not know the lot number of the oscor helios lead used for this procedure. There was no adverse impact to the patient and no extended hospitalization. The lead was returned for evaluation.

 
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Brand NameHELIOS, 5F UN-SHROUDED
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd.
palm harbor , FL 34683
7279372511
MDR Report Key8678376
Report Number1035166-2019-00048
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH05110U
Device Catalogue NumberH05110U
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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