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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD Back to Search Results
Model Number 0182
Medical Device Problem Codes Signal Artifact/Noise (1036); High impedance (1291); Defective Device (2588)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/09/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that this lead exhibited high out of range shock impedance measurements.Boston scientific technical services (ts) reviewed the data and a possible lead damage is suspected to be the cause of the impedance issues and the noisy signals.Troubleshooting was recommended by ts.At this time, the system remains in service.No adverse patient effects were reported.Additional information confirmed this patient will have a high-energy shock testing schedule.Physician is aware of the recommendation from ts.
 
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Brand Name
ENDOTAK RELIANCE SG
Common Device Name
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12221277
Report Number2124215-2021-20393
Device Sequence Number4477634
Product Code LWS
UDI-Device Identifier00802526531163
UDI-Public00802526531163
Combination Product (Y/N)Y
Initial Reporter CountryGM
PMA/510(K) Number
P910073/S043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/23/2021
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 Date10/12/2014
Device Model Number0182
Device Catalogue Number0182
Device Lot Number300851
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/11/2021
Initial Report FDA Received Date07/23/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
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