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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D176
Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  Injury  
Manufacturer Narrative
This investigation is ongoing.Upon additional information this investigation will be updated.
 
Event Description
It was reported that this device triggered error code 1007.A review by technical services (ts) noted that the device set end of life (eol) due to two charge times of forty five seconds in (b)(6) 2019.Ts noted that the device was malfunctioning and should be replaced.No adverse patient effects were reported.
 
Manufacturer Narrative
A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Review of device memory indicated that a charge timeout alert (45 seconds) had been recorded.The device case was opened, and visual inspection noted that one of the two high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, due to the extensive damage within the hv capacitor, assignable cause is undetermined but believed to be conductive foreign material, most likely anode particulate, which ultimately caused anode to cathode arcing.This capacitor issue impacted the device's ability to provide shock therapy because the hv capacitors could not be fully charged.
 
Event Description
It was reported that this device triggered error code 1007.A review by technical services (ts) noted that the device set end of life (eol) due to two charge times of forty five seconds in (b)(6) 2019.Ts noted that the device was malfunctioning and should be replaced.No adverse patient effects were reported.The device was explanted and will be returned.
 
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Brand Name
AUTOGEN
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9571584
MDR Text Key174674233
Report Number2124215-2020-00099
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/06/2020
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 Date11/17/2017
Device Model NumberD176
Device Catalogue NumberD176
Device Lot Number510076
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received01/09/2020
Supplement Dates Manufacturer Received01/17/2020
Supplement Dates FDA Received04/06/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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