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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number A209
Device Problems High impedance (1291); Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661); Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  Injury  
Event Description
It was reported that the patient underwent a replacement procedure for normal battery depletion.Prior to the procedure a 10 joule shock was delivered and yielded an impedance measurement of 120 ohms.It was noted that an x-ray had been taken a year earlier and indicated there was not a good electrode position.It was planned to first remove the capsule in the device pocket in order to lower the shock impedance.After the bag was closed and connected to the new device, another 10 joule synchronized shock with an impedance of 116 ohms occurred.They put the patient into ventricular fibrillation (vf) as desired by the physician, and the newly implanted s-icd detected the arrhythmia.Time to therapy was under 20 seconds.After the shock is delivered, a zero line appeared for about 10 seconds, but the patient still was in vf.The vf signals reappeared after approximately 10 more seconds, but the s-icd no longer detected every complex and no longer recognized a tachycardia arrhythmia.The shock impedance measurement was now at 3 ohms.External defibrillation was successful.Subsequently the new s-icd was attempted and not implanted.A new s-icd and electrode were implanted with no further issues and a shock impedance measurement of 72 ohms.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory visual inspection noted an arc mark on the pg case indicating that a shock was shorted to the pg case.This damaged the pg internally and caused the low shock lead impedance and detection issues noted in the field during the attempted implant.The device did not pass the automated electrical test due to the internal damage from the shock.
 
Event Description
It was reported that the patient underwent a replacement procedure for normal battery depletion.Prior to the procedure a 10 joule shock was delivered and yielded an impedance measurement of 120 ohms.It was noted that an x-ray had been taken a year earlier and indicated there was not a good electrode position.It was planned to first remove the capsule in the device pocket in order to lower the shock impedance.After the bag was closed and connected to the new device, another 10 joule synchronized shock with an impedance of 116 ohms occurred.They put the patient into ventricular fibrillation (vf) as desired by the physician, and the newly implanted s-icd detected the arrhythmia.Time to therapy was under 20 seconds.After the shock is delivered, a zero line appeared for about 10 seconds, but the patient still was in vf.The vf signals reappeared after approximately 10 more seconds, but the s-icd no longer detected every complex and no longer recognized a tachycardia arrhythmia.The shock impedance measurement was now at 3 ohms.External defibrillation was successful.Subsequently the new s-icd was attempted and not implanted.A new s-icd and electrode were implanted with no further issues and a shock impedance measurement of 72 ohms.No additional adverse patient effects were reported.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key13444767
MDR Text Key285044677
Report Number2124215-2021-40710
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110042/S043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/14/2022
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 Health Professional
Device Expiration Date11/11/2023
Device Model NumberA209
Device Catalogue NumberA209
Device Lot Number153500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2021
Initial Date FDA Received02/03/2022
Supplement Dates Manufacturer Received07/06/2022
Supplement Dates FDA Received07/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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