FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2061622
·
Received April 18, 2011
Report
- Report Number
- 2647346-2011-00561
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE, WITH DECEASING IMPEDANCE WITH ISOMETRIC EXERCISES. IT WAS FURTHER REPORTED THAT THERE WAS A POSSIBLE MODE SWITCH DUE TO BLANKED FLUTTER SEARCH ALGORITHM IN THE DEVICE. THE LEAD AND DEVICE REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDRL1 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Other | 1688TC COMPETITOR IMPLANTABLE PACING LEAD |