MAUDE Adverse Event Report: BIOTRONIK, INC. BIOTRONIK PACEMAKER/DEFIBRILLATOR; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number ILESTRO 7 DR-T DF-1

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 03/28/2022

Event Type  Injury  

Event Description

Biotronick defibrillator malfunctioned causing the implanted unit to shock the patient twice.The lead connection wire had fractured, this is implanted in the heart, the unit identified that the patient heart had stopped causing the two shocks first one followed by second 18 minutes later.Hospital records state this was a malfunction by the device, i contacted biotronik below after it happened to this person who refused to respond for months.(b)(6) best regards, (b)(6).Fda safety report id # (b)(4).

• Brand Name: BIOTRONIK PACEMAKER/DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): BIOTRONIK, INC.
• MDR Report Key: 14829702
• MDR Text Key: 294934747
• Report Number: MW5110512
• Device Sequence Number: 1
• Product Code: MRM
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ILESTRO 7 DR-T DF-1
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: WILL DISCLOSE LATER
• Patient Outcome(s): Disability; Life Threatening; Other; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White