FDA Adverse Event
Injury
Summary report: N
JADE 3 SSI
MDR report key: 3615644
·
Received February 8, 2014
Report
- Report Number
- 6000095-2014-00002
- Event Type
- Injury
- Date Received
- February 8, 2014
- Report Date
- December 30, 2013
- Manufacturer
- VITATRON MEDICAL B.V.
- Product Code
- DXY
- PMA / PMN Number
- P990001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF DIZZINESS. UPON FURTHER ANALYSIS, THE DEVICE CHECK SHOWED BATTERY DEPLETION. PREMATURE BATTERY DEPLETION IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85684 | JADE 3 SSI | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | VITATRON MEDICAL B.V. | JD340U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Hospitalization| R |