FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 3993482
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01898
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 11, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Removal / Correction Number
- Z-1440-2010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
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
PRODUCT EVENT SUMMARY: P1501DR DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO CHEST TIGHTNESS. THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471923 | ENRHYTHM DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | P1501DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization| R |