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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; PROGRAMMER, PACEMAKER
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BOSTON SCIENTIFIC CORPORATION; PROGRAMMER, PACEMAKER Back to Search Results
Model Number T165
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 12/31/2018
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 will be filed.
 
Event Description
Boston scientific received information that this implantable cardioverter defibrillator (icd) was explanted due to normal battery depletion (nbd).However, the physician noticed that the device appeared to have swollen.The device was returned for analysis.No additional adverse patient effects were reported.
 
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Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CLONMEL LIMITED
cashel road
,
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8317590
MDR Text Key135435400
Report Number2124215-2019-02828
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960040/S039
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 02/07/2019
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 Date03/08/2007
Device Model NumberT165
Device Catalogue NumberT165
Device Lot Number119048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/31/2018
Initial Date FDA Received02/07/2019
Date Device Manufactured03/09/2006
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age66 YR
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