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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; PERMANENT DEFIBRILLATOR ELECTRODES

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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; PERMANENT DEFIBRILLATOR ELECTRODES Back to Search Results
Model Number 0295
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2024
Event Type  malfunction  
Event Description
It was reported during a routine follow up, noise was observed on this right ventricular (rv) lead and the non-boston scientific right atrial (ra) lead.The physician suspects the "mirror image" noise to be the leads rubbing together.Technical services (ts) was consulted and provided troubleshooting suggestions with lead noise.At this time, the rv and ra lead remain in service.No adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE G
Type of Device
PERMANENT DEFIBRILLATOR ELECTRODES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key19000509
MDR Text Key338950330
Report Number2124215-2024-18999
Device Sequence Number1
Product Code NVY
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
P910073/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/04/2014
Device Model Number0295
Device Catalogue Number0295
Device Lot Number107352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2012
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
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