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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD Back to Search Results
Model Number 3501
Device Problems High impedance (1291); Failure to Sense (1559); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2023
Event Type  malfunction  
Event Description
It was reported that during an implantation procedure, the subcutaneous implantable cardioverter defibrillator (s-icd) system was an attempted implant due to the s-icd being damaged or defective.Subsequently, an new s-icd system was successfully implanted.No adverse patient effects were reported.
 
Event Description
It was reported that during an implantation procedure, the subcutaneous implantable cardioverter defibrillator (s-icd) system was an attempted implant due to the s-icd being damaged or defective.Subsequently, an new s-icd system was successfully implanted.No adverse patient effects were reported.Additional information was received indicating that during the procedure, the pulse generator would not interrogate and there were tones could not be elicited.When the device eventually connected, there was no sensing signal.High, out-of-range shock impedance measurements of greater than 400 ohms were also observed.Eventually, they realized the programmer was connecting to a spare device in the case cart, and the attempted s-icd was dead.Subsequently, the new s-icd system was implanted.No adverse patient effects were reported.
 
Manufacturer Narrative
The returned electrode was thoroughly inspected and analyzed.Resistance tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that during an implantation procedure, the subcutaneous implantable cardioverter defibrillator (s-icd) system was an attempted implant due to the s-icd being damaged or defective.Subsequently, an new s-icd system was successfully implanted.No adverse patient effects were reported.Additional information was received indicating that during the procedure, the pulse generator would not interrogate and there were tones could not be elicited.When the device eventually connected, there was no sensing signal.High, out-of-range shock impedance measurements of greater than 400 ohms were also observed.Eventually, they realized the programmer was connecting to a spare device in the case cart, and the attempted s-icd was dead.Subsequently, the new s-icd system was implanted.No adverse patient effects were reported.
 
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Brand Name
EMBLEM S-ICD
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 Key18380358
MDR Text Key331200177
Report Number2124215-2023-72860
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110042/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3501
Device Catalogue Number3501
Device Lot Number226297
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2023
Initial Date FDA Received12/21/2023
Supplement Dates Manufacturer Received12/15/2023
02/22/2024
Supplement Dates FDA Received12/28/2023
02/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2022
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 Age21 YR
Patient SexMale
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