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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND 2; PERMANENT PACEMAKER ELECTRODE
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BOSTON SCIENTIFIC CORPORATION FLEXTEND 2; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 4096
Device Problem Connection Problem (2900)
Patient Problem Bradycardia (1751)
Event Date 09/05/2019
Event Type  Injury  
Manufacturer Narrative
As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.
 
Event Description
It was reported that this right atrial (ra) lead's terminal pin was not properly inserted into the header of a pacemaker.Surgical intervention was performed and the pacemaker was explanted and replaced.The ra lead remains in service with a new device.No additional adverse patient effects were reported.
 
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Brand Name
FLEXTEND 2
Type of Device
PERMANENT PACEMAKER ELECTRODE
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
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key9270194
MDR Text Key164803424
Report Number2124215-2019-23421
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 11/02/2019
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 Date03/01/2013
Device Model Number4096
Device Catalogue Number4096
Device Lot Number175309
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/05/2019
Initial Date FDA Received11/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
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