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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. TB 4F TEMPORARY BIPOLAR PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY

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OSCOR INC. TB 4F TEMPORARY BIPOLAR PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 020022
Device Problems Electrical /Electronic Property Problem; Loose or Intermittent Connection
Event Type  Injury  
Manufacturer Narrative

Report source: country of incident occurrence - (b)(6). Pma 510(k): k861403 and k884866 are both applicable. Additional information has been requested, however not received as of date of this report. Conclusion not yet available as the investigation is on-going.

 
Event Description

The customer reported the sonde (catheter) plug had a loose connection and as a result the patient had to be resuscitated. With these sondes a couple problems occur that threaten the life of the patient. In addition there is a loose connection at the plug, so there is no stimulation. This is what happened today in the imc. The patient came with the av block iii°, came directly from the emergency department to the cath lab, immediately received the temporary pacemaker and in spite of the correct position of the sonde (catheter) the patient had to be resuscitated in the imc and an external stimulation by a defibrillator was necessary. It turned out that there was a loose connection of the plug.

 
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Brand NameTB 4F TEMPORARY BIPOLAR PACING LEAD
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
OSCOR INC.
3816 de soto blvd.
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 de soto blvd.
palm harbor FL 34683
Manufacturer Contact
doug myers
3816 de soto blvd.
palm harbor , FL 34683
7279372511
MDR Report Key7861685
Report Number1035166-2018-00084
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number020022
Device Catalogue Number020022
Device LOT NumberDP-06760
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/13/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number1035166-09/07/2018-01-R

Patient TREATMENT DATA
Date Received: 09/10/2018 Patient Sequence Number: 1
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