FDA Adverse Event
Injury
Summary report: N
ENPULSE
MDR report key: 2964501
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02295
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- November 16, 2012
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 407645 IMPLANTABLE PACING LEAD, (B)(6) 2005. (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 BY THE PATIENT THAT THE DEVICE "FLATLINED" AND WAS NOT WORKING. FOLLOW-UP INFORMATION FROM THE CLINIC DISCLOSED THAT THE DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR QUICKER THAN THE ESTIMATED LONGEVITY. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67350 | ENPULSE | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | E2DR01AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 407452 IMPLANTABLE PACING LEAD |