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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0273
Device Problems Pocket Stimulation (1463); High Capture Threshold (3266)
Patient Problem Muscle Stimulation (1412)
Event Date 03/02/2020
Event Type  Injury  
Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Event Description
It was reported that this right ventricular (rv) lead exhibited high threshold and caused muscle stimulation to the patient.This rv lead was explanted.The patient was also given intravenous antibiotics.No additional adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key9972995
MDR Text Key188056015
Report Number2124215-2020-08024
Device Sequence Number1
Product Code NVY
UDI-Device Identifier00802526601811
UDI-Public00802526601811
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910073/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/27/2021
Device Model Number0273
Device Catalogue Number0273
Device Lot Number104574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2020
Date Device Manufactured11/27/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
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