inforMED
InjuryKRG

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Received Jul 14, 2023 · Event occurred Jan 1, 2004

Report 2124215-2023-37133 · MDR key 17324465

Device

Generic name

Implantable Cardioverter Defibrillator (icd)

Model number

T135

Catalog number

T135

Lot number

931450

Product problems

  • Inappropriate/Inadequate Shock/Stimulation
  • Inappropriate/Inadequate Shock/Stimulation

Patient

40 YR · Female

  • Electric Shock
  • Convulsion/Seizure
  • Electric Shock
  • Convulsion/Seizure

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED MULTIPLE ELECTRIC SHOCKS SEVERAL YEARS AGO THAT CAUSED THE PATIENT TO HAVE SEIZURES. IT WAS NOTED THAT THE SHOCKS MAY HAVE BEEN INAPPROPRIATE. TECHNICAL SERVICES (TS) DISCUSSED DEVICE OPERATION AND POSSIBLE ELECTROMAGNETIC INTERFERENCE (EMI) INTERACTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS EXPLANTED SEVERAL YEARS AGO FOR NORMAL BATTERY DEPLETION AND REPLACED WITH A NEW ICD.