FDA Adverse Event
Malfunction
Summary report: N
ENPULSE
MDR report key: 2130070
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03296
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 25, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S032
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING PRESYNCOPE LIGHTHEADEDNESS. IT WAS ALSO REPORTED THAT THE DEVICE SHOWED HIGH RATE EPISODES AND TWO OF THE THREE HIGH RATE EPISODES WERE DURING A MODE SWITCH. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENPULSE | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | E2DR21 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other | 4092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |