PARADYM
Report
- Report Number
- 1000165971-2014-00555
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- September 29, 2014
- Report Date
- September 29, 2014
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- MRM
- PMA / PMN Number
- PP060027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
ON (B)(6) 2014, PRIOR TO DEVICE IMPLANTATION, THE DEVICE WAS REPORTEDLY INTERROGATED IN ITS BOX, SHOWING NORMAL CHARGE TIME TEST AND NORMAL BATTERY STATUS. DURING INTERROGATION AT IMPLANTATION FOLLOWING DEVICE CONNECTION, SEVERAL WARNING MESSAGES WERE DISPLAYED, INDICATING THAT 3 RESETS OCCURRED, AND THAT THE RRT (RECOMMENDED REPLACEMENT TIME) HAD BEEN DETECTED. PATIENT CARE RECOMMENDATIONS WERE PROVIDED. THE DEVICE WAS RE-INTERROGATED ON (B)(6) 2014 AND THE RRT WARNING MESSAGE WAS STILL DISPLAYED. THE DEVICE WAS EXPLANTED ON (B)(6) 2014 AND WILL BE RETURNED FOR EXPERTISE.
ON (B)(6) 2014, PRIOR TO DEVICE IMPLANTATION, THE DEVICE WAS REPORTEDLY INTERROGATED IN ITS BOX, SHOWING NORMAL CHARGE TIME TEST AND NORMAL BATTERY STATUS. DURING INTERROGATION AT IMPLANTATION FOLLOWING DEVICE CONNECTION, SEVERAL WARNING MESSAGES WERE DISPLAYED, INDICATING THAT 3 RESETS OCCURRED, AND THAT THE RRT (RECOMMENDED REPLACEMENT TIME) HAD BEEN DETECTED. PATIENT CARE RECOMMENDATIONS WERE PROVIDED. THE DEVICE WAS RE-INTERROGATED ON (B)(6) 2014 AND THE RRT WARNING MESSAGE WAS STILL DISPLAYED. THE DEVICE WAS EXPLANTED ON (B)(6) 2014 AND WILL BE RETURNED FOR EXPERTISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610241 | PARADYM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | MRM | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | PARADYM RF DR 9550 | 2802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |