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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE LEAD Back to Search Results
Model Number 0186
Medical Device Problem Codes Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Defective Device (2588)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Information indicates this lead is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted and replaced due to observations of an insulation breach, noise, oversensing with no pacing inhibition observed and inappropriate anti-tachycardia pacing (atp) therapy.There were no additional adverse patient effects.
 
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Brand Name
ENDOTAK RELIANCE G
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11741935
Report Number2124215-2021-10844
Device Sequence Number14559682
Product Code LWS
UDI-Device Identifier00802526531200
UDI-Public00802526531200
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/28/2021
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
Operator of Device Lay User/Patient
Device Expiration Date08/08/2008
Device Model Number0186
Device Catalogue Number0186
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/01/2021
Initial Report FDA Received Date04/28/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age46 YR
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