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

Model Number 3501

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Defective Device (2588); Device Dislodged or Dislocated (2923)

Patient Problems Twiddlers Syndrome (2114); Electric Shock (2554); No Code Available (3191); Twiddlers Syndrome (4563)

Event Date 12/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient received an inappropriate shock involving this device nd electrode.The patient was going to be hospitalized to perform an x-ray.A review of the device data by engineering noted that low out of range shock impedance measurements were seen, and the day after the shock was delivered due to non physiological signal oversensing likely due to twiddlers syndrome, a charge timeout error was seen.It was evident that the shock coil of the electrode was in direct contact with the device, suggesting that the electrode had dislodged, the patient should be considered unprotected, and alternate therapy should be arranged prior to an urgent device replacement.It was not possible to determine the cause of the charge timeouts and low impedance measurements.The device and electrode were subsequently explanted and will be returned.No additional adverse patient effects were reported.

Event Description

It was reported that this patient received an inappropriate shock involving this device nd electrode.The patient was going to be hospitalized to perform an x-ray.A review of the device data by engineering noted that low out of range shock impedance measurements were seen, and the day after the shock was delivered due to non physiological signal oversensing likely due to twiddlers syndrome, a charge timeout error was seen.It was evident that the shock coil of the electrode was in direct contact with the device, suggesting that the electrode had dislodged, the patient should be considered unprotected, and alternate therapy should be arranged prior to an urgent device replacement.It was not possible to determine the cause of the charge timeouts and low impedance measurements.The device and electrode were subsequently explanted and returned.No additional 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.Inspection of the lead body and electrode tip found no anomalies.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.The electrode was sent for additional testing to look at the sense b sensing ring for possible arc marks.Additional testing concluded that there was localized corrosion on the sense b sensing ring.It was not conclusive whether this occurred during use or after explant.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11181722
• MDR Text Key: 227194528
• Report Number: 2124215-2020-26824
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 184919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR