PARADYM 2
Received Apr 2, 2026 · Event occurred Mar 6, 2026
Report 1000165971-2026-00205 · MDR key 24764316
Device
Generic name
Implantable Cardioverter Defibrillator (non-crt)
Manufacturer
Sorin Group Italia S.r.l. - Crm FacilityModel number
PARADYM 2 VR 8252Catalog number
TDF003C
Product problems
- Failure to Deliver Shock/Stimulation
Patient
NA · Unknown
- Ventricular Fibrillation
Narrative
Description of Event or Problem
REPORTEDLY, THE PATIENT GET SIX SHOCKS IN ROW BUT THE DEVICE BROKE UP TO DELIVER. THE PATIENT HAD TO BE RESUSCITATED AFTER VF. SOME ARTEFACTS/NOISE ARE RECORDED ON THE VENTRICULAR CHANNEL (FOR EXAMPLE ON (B)(6) 2024 AND ON (B)(6) 2025).
Additional Manufacturer Narrative
- THE SUBJECT ICD PARADYM2 VR S/N (B)(6), WAS IMPLANTED IN 2015 WITH A RV LEAD VOLTA MANUFACTURED BY BIOTRONIK. THE ICD VOLTAGE WAS AT 2,67V ON (B)(6) 2026, NEAR TO THE RRT (2,65V) - BETWEEN (B)(6) 2025 AND (B)(6) 2026, THE RV LEAD IMPEDANCE, THE RV AND SVC COIL CONTINUITY ARE STABLE. ON (B)(6) 2024 AND (B)(6) 2025, VENTRICULAR OVERSENSING EPISODES WERE RECORDED. 558 NON-SUSTAINED EPISODES WERE DETECTED. ON (B)(6) 2026, 6 SHOCKS WERE DELIVERED. ACCORDING TO THE CURRENT PROGRAMMING VENTRICULAR FIBRILLATION WAS DETECTED, SHOCKS WERE DELIVERED. - FOR THESE 6 SHOCKS, THE SHOCKS COULD NOT BE TOTALLY DELIVERED, DUE THE DETECTION OF AN OVERLOAD. OVERLOAD (I.E. THE DETECTION OF LOW SHOCK IMPEDANCE) REFERS TO A PROTECTION MECHANISM DESIGNED TO PREVENT PERMANENT ICD DAMAGE WHEN A SHORT CIRCUIT IS DETECTED BETWEEN THE ICD CAN AND THE DEFIBRILLATION LEAD WITHIN THE FIRST MICROSECONDS OF THE SHOCK PULSE. THIS BEHAVIOR CORRESPONDS TO THE ICD SPECIFICATIONS. A SHORT CIRCUIT COULD OCCUR DURING A SHOCK DELIVERY WHEN THE LEAD INSULATION IS COMPROMISED AND IN CONTACT WITH THE CAN. WHEN OVERLOAD IS DETECTED, THE PROGRAMMED SHOCK ENERGY IS NOT DELIVERED. DUE TO THE ICD VOLTAGE MEASURE AND THE POSSIBLE RV LEAD ISSUE, IT WAS RECOMMENDED TO REPLACE THE DEFIBRILLATION SYSTEM.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.
Description of Event or Problem
REPORTEDLY, THE PATIENT GET SIX SHOCKS IN ROW BUT THE DEVICE BROKE UP TO DELIVER. THE PATIENT HAD TO BE RESUSCITATED AFTER VF. SOME ARTEFACTS/NOISE ARE RECORDED ON THE VENTRICULAR CHANNEL (FOR EXAMPLE ON 26 SEPT 2024 AND ON 14 DEC 2025).