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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE DEFIBRILLATION LEAD
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE DEFIBRILLATION LEAD Back to Search Results
Model Number 0170
Medical Device Problem Codes Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Defective Device (2588); High Capture Threshold (3266)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out-of-range (oor) pacing impedances, measuring greater than 3000 ohms.It was noted the lead was fractured, and there was insulation damage.In addition, high pacing thresholds, and noise was observed.Subsequently, a revision procedure was performed.The rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE SG
Common Device Name
IMPLANTABLE DEFIBRILLATION LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9947197
Report Number2124215-2020-05956
Device Sequence Number19371248
Product Code LWS
UDI-Device Identifier00802526373282
UDI-Public00802526373282
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/09/2020
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 Date06/19/2009
Device Model Number0170
Device Catalogue Number0170
Device Lot Number100320
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/13/2020
Initial Report FDA Received Date04/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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