FDA Adverse Event
Injury
Summary report: N
RELIA S
MDR report key: 3993959
·
Received August 8, 2014
Report
- Report Number
- 3008973940-2014-00299
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOCTOR TREATING THE PATIENT HAS ADVISED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAS BEEN MALFUNCTIONING. THE IPG 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 |
|---|---|---|---|---|---|---|---|
| 470703 | RELIA S | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC SINGAPORE OPERATIONS | RES01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Hospitalization| R |