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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Failure to Select Signal (1582); Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Noise, Audible (3273)
Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 11/16/2019
Event Type  Injury  
Manufacturer Narrative
The device was received and is undergoing laboratory analysis.This report will be updated when analysis is complete.(b)(4).
 
Event Description
It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) and associated electrode received an inappropriate shock.Interrogation revealed error codes for power supply (ps), charge time out (ct), and long charge (lc).Technical services discussed that device replacement was required as any device therapy would likely be delayed due to the long charge times and the power supply errors.Additionally, electrode replacement was recommended; although there was no evidence of an impairment, x-rays showed there was some excess electrode coiled in the pocket behind the device.The ps error could be due to an electrical short between the device and electrode.Technical services also reviewed the shock episode and confirmed it was inappropriate, due to oversensing of noise with low r-wave amplitudes.The field representative later confirmed that the device and electrode were explanted and replaced the following week.It was noted the device was not able to be interrogated but was still emitting beeping tones.The explanted products were expected to be returned for laboratory analysis.
 
Event Description
It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) and associated electrode received an inappropriate shock.Interrogation revealed error codes for power supply (ps), charge time out (ct), and long charge (lc).Technical services discussed that device replacement was required as any device therapy would likely be delayed due to the long charge times and the power supply errors.Additionally, electrode replacement was recommended; although there was no evidence of an impairment, x-rays showed there was some excess electrode coiled in the pocket behind the device.The ps error could be due to an electrical short between the device and electrode.Technical services also reviewed the shock episode and confirmed it was inappropriate, due to oversensing of noise with low r-wave amplitudes.The field representative later confirmed that the device and electrode were explanted and replaced the following week.It was noted the device was not able to be interrogated but was still emitting beeping tones.The explanted products were returned for laboratory analysis.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes as no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: the returned device was thoroughly inspected and analyzed.Visual inspection identified scratches on the device case, electrical overstress damage to the header in addition to being cracked, and a hole above the antenna and in the seal plug.It was also noted that the gold around the feed through and in the feed through wires was burned.The device had no telemetry and could not be interrogated.The device case was removed and electrical overstress damage was observed to the high voltage capacitor flex and header region.The electrical overstress damage is suspected to have been caused by a void in the insulative material at the feed through exposing the high voltage, antenna, and sense wires.Analysis of data previously obtained confirmed the display of error messages but the observed electrical allegations and inappropriate shock could not be confirmed.Labeling review: review of labeling determined the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to the labeling.The manual was unlikely to be the cause of the reported complaint.Investigation conclusion: no further actions are considered necessary and the complaint investigation conclusion code is cause not established.Patient code 3191 captures the reportable event of surgery, performed to explant and replace the device.
 
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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
MDR Report Key9638058
MDR Text Key176639470
Report Number2124215-2019-28705
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526544101
UDI-Public00802526544101
Combination Product (y/n)N
PMA/PMN Number
P110042/S043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/03/2020
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 Date06/02/2018
Device Model NumberA209
Device Catalogue NumberA209
Device Lot Number117217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Initial Date Manufacturer Received 11/18/2019
Initial Date FDA Received01/28/2020
Supplement Dates Manufacturer Received07/16/2020
Supplement Dates FDA Received09/03/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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