FDA Adverse Event
Injury
Summary report: N
ENPULSE
MDR report key: 2964402
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02298
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- April 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AFTER THE USE BEFORE DATE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR. IT WAS REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 66952 | ENPULSE | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | E2DR21AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00091 YR | Hospitalization| R | 4024-58 IMPLANTABLE PACING LEAD |