InjuryKRG
PROGRAMMER, PACEMAKER
Received Dec 25, 2024 · Event occurred Jan 1, 2021
Report 2124215-2024-81885 · MDR key 21016454
Device
Generic name
Programmer, Pacemaker
Manufacturer
Boston Scientific CorporationModel number
T175Catalog number
T175
Lot number
124423
Product problems
- Data Problem
- Noise, Audible
- Data Problem
- Noise, Audible
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS MAKING AUDIBLE TONE SIMILAR TO AN AMBULANCE SIREN. MOREOVER, THE PATIENT STATED THAT 3 OR 4 YEARS AGO, THE PHYSICIAN TURNED OFF THE DEVICE DUE TO LEAD FRACTURE. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) DISCUSSED AUDIBLE TONES AND ADVISED PATIENT TO CONTACT CURRENT CLINICIAN. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.