FDA Adverse Event
Injury
Summary report: N
PARADYM
MDR report key: 3873666
·
Received June 16, 2014
Report
- Report Number
- 1000165971-2014-00355
- Event Type
- Injury
- Date Received
- June 16, 2014
- Date of Event
- March 14, 2014
- Report Date
- May 22, 2014
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- MRM
- PMA / PMN Number
- PP980049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED. THE BATTERY DEPLETION WAS MORE LIKELY DUE TO THE NUMEROUS CHARGES AND SHOCKS DELIVERED IN A SHORT PERIOD.
Description of Event or Problem · 1
REPORTEDLY, THE SUBJECT DEVICE SHOWED AN EARLY BATTERY DEPLETION. IT WILL BE EXPLANTED AND RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
REPORTEDLY, THE SUBJECT DEVICE SHOWED AN EARLY BATTERY DEPLETION. IT WILL BE EXPLANTED AND RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
REPORTEDLY, THE SUBJECT DEVICE SHOWED AN EARLY BATTERY DEPLETION. IT WILL BE EXPLANTED AND RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352144 | PARADYM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | MRM | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | PARADYM VR 8250 | 2751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |