FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 3945908
·
Received July 21, 2014
Report
- Report Number
- 3004209178-2014-13274
- Event Type
- Malfunction
- Date Received
- July 21, 2014
- Report Date
- June 26, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNEXPLAINED SYNCOPE. THE PHYSICIAN OBTAINED A HOLTER MONITOR AND IT SHOWED A LONGER THAN PROGRAMMED ATRIAL TO VENTRICULAR PATTERN. THE PHYSICIAN QUESTION IF THIS WAS DUE TO CAPTURE MANAGEMENT. ADDITIONAL TESTING WILL BE OBTAINED. NO CHANGES HAVE BEEN MADE AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425924 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00013 YR | 4470, 4469 COMPETITOR LEADS |