FDA Adverse Event
Injury
Summary report: N
ADAPTA
MDR report key: 3051802
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05984
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- January 7, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT THEY PRESENTED TO THE EMERGENCY ROOM AS THE DEVICE WAS NOT "PACING PROPERLY." THE PATIENT ALSO REPORTED THAT DEVICE SETTINGS WERE CHANGED. THE PATIENT LATER REPORTED CHEST PAINS AND A "SHOCKING FEELING NEAR THE HEART". MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149146 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Hospitalization| R | 5076 (X2) IMPLANTABLE PACING LEAD |