MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD MODEL A219; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Failure of Implant (1924); Pain (1994); Shock from Patient Lead(s) (3162)

Event Date 08/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 i got as bottle digging with my son when i received a shock from my defibrillator.I told my son we needed to go and as i was walking it shocked me 4 more times knocking me to my knees and screaming in pain.I had my son dial 911 and arrived at the emergency room.They had (b)(6) from (b)(6) cardiology come see me and she told me it was a malfunction and i needed to have my wife drive me 2 hours to (b)(6) and meet with dr.(b)(6) who had implanted my icd on (b)(6) 2022.Upon my arrival he was upset that i wasn't transported by ambulance even stated my heart could of stopped had this happened again.He had the nurse shut the device off and proceeded to admit me.My wife and i were told this was a malfunction and they needed to open me back up to see what went on.They put me under on (b)(6) 2022 but decided to do nothing at that point and dr.(b)(6) called my wife and waited for me to come to and said he was going to remove my current icd and implant a new one.I have brugada syndrome and i'm very upset that now i have to live in fear of another malfunction and my possible death.Something needs to be done about this immediately.I was hooked up to a boston scientific machine as well as had an ekg.Fda safety report id# (b)(4).

• Brand Name: EMBLEM MRI S-ICD MODEL A219
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15282923
• MDR Text Key: 298607246
• Report Number: MW5111680
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A219
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADDERALL XR; QUINDINE; SETRALINE
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White