MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Migration (4003)

Patient Problems Electric Shock (2554); Twiddlers Syndrome (4563)

Event Date 09/12/2019

Event Type  Injury  

Event Description

It was reported that review of stored data for this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode, noted a flat line on the presenting electrogram with no markers.Further review of device data noted all events in the logbook showed a flat line with very few markers.Two untreated episodes were recorded one month post implant that contained noise and occasional big excursions off the baseline.Stored atrial fibrillation (af) episodes were also observed that showed fuzzy noise on the baseline with very few markers.Additionally, shock impedance measurements had been very low or at zero ohms beginning one month post device and electrode implant.Technical services (ts) discussed potential causes.An x-ray was taken and the electrode was noted to be pulled out of position and wrapped around the s-icd in the pocket.The patient was noted to suffer from twiddler's syndrome.Surgical intervention was undertaken.The electrode was explanted and replaced.Approximately one month later, this s-icd and replacement electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock, as well as storage of an untreated episode.Noise was easily reproducible with arm movements.Ts discussed the potential of device migration and discussed the option of performing an x-ray for review of system placement.The position of the device was reviewed and was noted to be more horizontal compared to the implant procedure, when the placement was more vertical.Twiddling of the device was suspected to be a potential factor.The physician reprogrammed the device to a single therapy zone at this time.No additional adverse patient effects were reported.This device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that review of stored data for this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode, noted a flat line on the presenting electrogram with no markers.Further review of device data noted all events in the logbook showed a flat line with very few markers.Two untreated episodes were recorded one month post implant that contained noise and occasional big excursions off the baseline.Stored atrial fibrillation (af) episodes were also observed that showed fuzzy noise on the baseline with very few markers.Additionally, shock impedance measurements had been very low or at zero ohms beginning one month post device and electrode implant.Technical services (ts) discussed potential causes.An x-ray was taken and the electrode was noted to be pulled out of position and wrapped around the s-icd in the pocket.The patient was noted to suffer from twiddler's syndrome.Surgical intervention was undertaken.The electrode was explanted and replaced.Approximately one month later, this s-icd and replacement electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock, as well as storage of an untreated episode.Noise was easily reproducible with arm movements.Ts discussed the potential of device migration and discussed the option of performing an x-ray for review of system placement.The position of the device was reviewed and was noted to be more horizontal compared to the implant procedure, when the placement was more vertical.Twiddling of the device was suspected to be a potential factor.The physician reprogrammed the device to a single therapy zone at this time.No additional adverse patient effects were reported.This device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.It was reported that during additional review of the x-ray at a subsequent in-clinic follow up, the electrode was noted to have moved slightly.Ongoing twiddling of the device was suspected.The physician reprogrammed the primary sensing vector.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that review of stored data for this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode, noted a flat line on the presenting electrogram with no markers.Further review of device data noted all events in the logbook showed a flat line with very few markers.Two untreated episodes were recorded one month post implant that contained noise and occasional big excursions off the baseline.Stored atrial fibrillation (af) episodes were also observed that showed fuzzy noise on the baseline with very few markers.Additionally, shock impedance measurements had been very low or at zero ohms beginning one month post device and electrode implant.Technical services (ts) discussed potential causes.An x-ray was taken and the electrode was noted to be pulled out of position and wrapped around the s-icd in the pocket.The patient was noted to suffer from twiddler's syndrome.Surgical intervention was undertaken.The electrode was explanted and replaced.Approximately one month later, this s-icd and replacement electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock, as well as storage of an untreated episode.Noise was easily reproducible with arm movements.Ts discussed the potential of device migration and discussed the option of performing an x-ray for review of system placement.The position of the device was reviewed and was noted to be more horizontal compared to the implant procedure, when the placement was more vertical.Twiddling of the device was suspected to be a potential factor.The physician reprogrammed the device to a single therapy zone at this time.No additional adverse patient effects were reported.This device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.It was reported that during additional review of the x-ray at a subsequent in-clinic follow up, the electrode was noted to have moved slightly.Ongoing twiddling of the device was suspected.The physician reprogrammed the primary sensing vector.If information is provided in the future, a supplemental report will be issued.It was reported that an additional inappropriate shock was delivered due to ongoing oversensing of noise.The patient was admitted to the hospital.The noise was suspected to be related to potential myopotentials.Further discussion was had regarding the potential movement of the system and the option of obtaining updated x-rays was discussed.The physician planned to get a new set of x-rays and have the patient follow up in clinic after discharged.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that review of stored data for this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode, noted a flat line on the presenting electrogram with no markers.Further review of device data noted all events in the logbook showed a flat line with very few markers.Two untreated episodes were recorded one month post implant that contained noise and occasional big excursions off the baseline.Stored atrial fibrillation (af) episodes were also observed that showed fuzzy noise on the baseline with very few markers.Additionally, shock impedance measurements had been very low or at zero ohms beginning one month post device and electrode implant.Technical services (ts) discussed potential causes.An x-ray was taken and the electrode was noted to be pulled out of position and wrapped around the s-icd in the pocket.The patient was noted to suffer from twiddler's syndrome.Surgical intervention was undertaken.The electrode was explanted and replaced.Approximately one month later, this s-icd and replacement electrode exhibited oversensing of noise that resulted in delivery of an inappropriate shock, as well as storage of an untreated episode.Noise was easily reproducible with arm movements.Ts discussed the potential of device migration and discussed the option of performing an x-ray for review of system placement.The position of the device was reviewed and was noted to be more horizontal compared to the implant procedure, when the placement was more vertical.Twiddling of the device was suspected to be a potential factor.The physician reprogrammed the device to a single therapy zone at this time.No additional adverse patient effects were reported.This device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.It was reported that during additional review of the x-ray at a subsequent in-clinic follow up, the electrode was noted to have moved slightly.Ongoing twiddling of the device was suspected.The physician reprogrammed the primary sensing vector.If information is provided in the future, a supplemental report will be issued.It was reported that an additional inappropriate shock was delivered due to ongoing oversensing of noise.The patient was admitted to the hospital.The noise was suspected to be related to potential myopotentials.Further discussion was had regarding the potential movement of the system and the option of obtaining updated x-rays was discussed.The physician planned to get a new set of x-rays and have the patient follow up in clinic after discharged.If information is provided in the future, a supplemental report will be issued.It was reported that updated x-rays were obtained, however, noted nothing new.Programming changes were made to the sensing vector and monitoring will be continued.No adverse patient effects were reported.This device remains in service.

• Brand Name: EMBLEM MRI 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 Key: 12686444
• MDR Text Key: 278084346
• Report Number: 2124215-2021-32024
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2022

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: Lay User/Patient
• Device Expiration Date: 12/18/2020
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 239416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 10/13/2021; 05/13/2022; 05/25/2022
• Supplement Dates FDA Received: 12/19/2021; 05/21/2022; 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male