FDA Adverse Event
Malfunction
Summary report: N
PARADYM
MDR report key: 5362866
·
Received January 13, 2016
Report
- Report Number
- 1000165971-2016-00029
- Event Type
- Malfunction
- Date Received
- January 13, 2016
- Date of Event
- January 4, 2016
- Report Date
- January 7, 2016
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- LWS
- PMA / PMN Number
- PP980049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A STANDARD FOLLOW-UP ON (B)(6) 2016, 3 WARNING MESSAGES WERE DISPLAYED: "[3] LOW SHOCK IMPEDANCE. DEFIBRILLATION SYSTEM INEFFECTIVE"; "[48] MAX SHOCK ENERGY INEFFECTIVE ON (B)(6) 2016"; "[46] HIGH SHOCK IMPEDANCE DETECTED ON (B)(6) 2016: DEFIBRILLATION SYSTEM INEFFECTIVE." NINE SHOCKS WERE DELIVERED, ALL OF THEM WITH STORED ENERGY = 41.9J AND DELIVERED ENERGY = 0J. THE SHOCK LEAD INTEGRITY CURVE IS STABLE AND IN THE NORMAL RANGE. IN THE MEMORIES OF THE DEVICE, EGM EPISODES WITH ATRIAL UNDERSENSING WERE RECORDED. THE PHYSICIAN CHANGED ATRIAL SENSITIVITY FROM 0.4 MV TO 0.2MV. A NEW FOLLOW-UP WAS SCHEDULED ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23110 | PARADYM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | LWS | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | PARADYM DR 8550 | 2408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |