Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR EMBLEM S-ICD ELECTRODE; IMPLANTABLE LEAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OSCOR EMBLEM S-ICD ELECTRODE; IMPLANTABLE LEAD Back to Search Results
Model Number 3401
Device Problems Failure to Sense (1559); Low impedance (2285)
Patient Problem No Code Available (3191)
Event Date 08/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The explanted electrode was returned and is undergoing laboratory analysis.This report will be updated when analysis is complete.
 
Event Description
It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an appropriate shock for ventricular fibrillation (vf).Upon device interrogation, a red warning screen was displayed on the programmer.It was noted the shock impedance measurement for the delivered shock was low, out-of-range, at 5 ohms.A review of all sense vectors showed no signals.Error codes ct (charge time out) and lt (long charge time) were observed.Technical services discussed replacement of the device and electrode.The patient was hospitalized, and the s-icd system was explanted and replaced six days later.It was noted there was difficulty extracting the electrode via the xiphoid incision, and a surgeon was called in to assist.Subsequently, the electrode was removed successfully and a new s-icd system was implanted.No additional adverse patient effects were reported.The explanted products were returned for analysis.
 
Manufacturer Narrative
Patient code 3191 captures the reportable event of surgery.The explanted electrode was returned and is undergoing laboratory analysis.This report will be updated when analysis is complete.The returned electrode was thoroughly inspected and analyzed.Resistance tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly and electrode body found no anomalies.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an appropriate shock for ventricular fibrillation (vf).Upon device interrogation, a red warning screen was displayed on the programmer.It was noted the shock impedance measurement for the delivered shock was low, out-of-range, at 5 ohms.A review of all sense vectors showed no signals.Error codes ct (charge time out) and lt (long charge time) were observed.Technical services discussed replacement of the device and electrode.The patient was hospitalized, and the s-icd system was explanted and replaced six days later.It was noted there was difficulty extracting the electrode via the xiphoid incision, and a surgeon was called in to assist.Subsequently, the electrode was removed successfully and a new s-icd system was implanted.No additional adverse patient effects were reported.The explanted products were expected to be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EMBLEM S-ICD ELECTRODE
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
OSCOR
palm harbor FL
MDR Report Key10687831
MDR Text Key211638942
Report Number2124215-2020-20843
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526585968
UDI-Public00802526585968
Combination Product (y/n)N
PMA/PMN Number
P110042/S043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/16/2021
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 Date02/01/2019
Device Model Number3401
Device Catalogue Number3401
Device Lot NumberA142703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Initial Date Manufacturer Received 08/20/2020
Initial Date FDA Received10/15/2020
Supplement Dates Manufacturer Received11/24/2020
Supplement Dates FDA Received01/16/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-