MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Failure to Sense (1559); Low impedance (2285); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (4563)

Event Date 09/12/2019

Event Type  Injury  

Event Description

It was reported that review of stored data for the subcutaneous implantable cardioverter defibrillator (s-icd) and this 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 as well 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 have 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.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that review of stored data for the subcutaneous implantable cardioverter defibrillator (s-icd) and this 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 as well 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 have 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.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

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.Microscopic inspections of the terminal pin assembly and electrode body found no anomalies.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 review of stored data for the subcutaneous implantable cardioverter defibrillator (s-icd) and this 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 as well 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 have 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.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12683067
• MDR Text Key: 277945079
• Report Number: 2124215-2021-25680
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S077
• 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
• Report Date: 12/19/2021

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: 12/01/2019
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 111530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 09/22/2021; 11/03/2021
• Supplement Dates FDA Received: 10/24/2021; 12/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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