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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE LEAD

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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE LEAD Back to Search Results
Model Number 0273
Device Problems Pacing Problem (1439); Failure to Sense (1559); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2023
Event Type  Injury  
Event Description
It was reported that this right ventricular (rv) lead got its tip damaged while the patient underwent a procedure, which caused it to be unable to sense or deliver pacing, so it was capped and surgically abandoned.A new device was implanted.No additional adverse patient effects were reported.
 
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Brand Name
ENDOTAK RELIANCE
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18127382
MDR Text Key327997545
Report Number2124215-2023-63843
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 Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/13/2023
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
Device Operator Lay User/Patient
Device Expiration Date03/21/2021
Device Model Number0273
Device Catalogue Number0273
Device Lot Number101877
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2023
Initial Date FDA Received11/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
Patient SexMale
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