FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 4834063
·
Received June 10, 2015
Report
- Report Number
- 3004209178-2015-11131
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- April 28, 2015
- Report Date
- April 28, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 IMPLANTABLE PULSE GENERATOR (IPG) WAS STUCK IN AN UNSEEN EPISODE. THE DIAGNOSTICS ONLY SHOWED SOME MODE SWITCHING AND THE ATRIAL ARRHYTHMIA TREND WAS BLACK. REPROGRAMMING OPTIONS WERE DISCUSSED 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 |
|---|---|---|---|---|---|---|---|
| 373437 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | 5076-45 LEAD, 4092-52 LEAD |