MAUDE Adverse Event Report: OSCOR EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3401

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

Patient Problems Electric Shock (2554); No Code Available (3191)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.(b)(4).

Event Description

It was reported that the patient received two inappropriate shocks for oversensing of noise.It was noted the patient had a left ventricular assist device (lvad) implanted five months earlier.Boston scientific technical services (ts) suggested programming the vector to alternate, however it was determined there was no sensing in that vector.Ts further suggested obtaining an x-ray.The field representative programmed therapy off in the subcutaneous implantable cardioverter defibrillator (s-icd) and the patient would be monitored.The noise was determined to be due to the interaction between the device and lvad.It was noted the physician was considering placing a transvenous implantable cardioverter defibrillator (icd).The s-icd and electrode remain implanted and no additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): OSCOR; palm harbor FL
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9970782
• MDR Text Key: 188005231
• Report Number: 2124215-2020-06638
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: 00802526585968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2020

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 Date: 12/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A140364
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2020
• Initial Date FDA Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR