FDA Adverse Event
Injury
Summary report: N
RELIA SR
MDR report key: 3993335
·
Received August 8, 2014
Report
- Report Number
- 3008973940-2014-00309
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 23, 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 IMPLANTABLE PULSE GENERATOR (IPG) DID NOT REACH LONGEVITY EXPECTATIONS. THE THRESHOLDS FOR THE LEFT VENTRICULAR (LV) LEAD WERE 2.5 VOLTS AND OUTPUT WAS KEPT AT 5 VOLTS. 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 |
|---|---|---|---|---|---|---|---|
| 470587 | RELIA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC SINGAPORE OPERATIONS | RESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR | Hospitalization| R | 5071-35 |