FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 1802862
·
Received August 17, 2010
Report
- Report Number
- 6000144-2010-04210
- Event Type
- Injury
- Date Received
- August 17, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
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
THE PATIENT REPORTED FEELING SLIGHTLY SHORT OF BREATH AND LIGHTHEADED SINCE DEVICE REPLACEMENT, AND QUESTIONED IF THE DEVICE HAD THE SAME PROGRAMMING AS THE PREVIOUSLY IMPLANTED DEVICE. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THERE WERE NO DEVICE PROBLEMS, THAT THE DEVICE WAS PROGRAMMED THE SAME, AND THAT THE PATIENT WAS PUT ON MEDICATION FOR SHORTNESS OF BREATH ABOUT EIGHT DAYS AFTER IMPLANT. THE DEVICE REMAINS IN USE. NO FURTHER 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. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other | 4457 COMPETITOR IMPLANTABLE PACING LEAD| 4470 COMPETITOR IMPLANTABLE PACING LEAD |