FDA Adverse Event
Malfunction
Summary report: N
ENPULSE
MDR report key: 2051684
·
Received April 12, 2011
Report
- Report Number
- 6000144-2011-01541
- Event Type
- Malfunction
- Date Received
- April 12, 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
- 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 FELT "SKIPPED BEATS" AND WAS FEELING TIRED, SHORT OF BREATH AND HAD CHEST PAIN. THERE WAS SUSPECTED UNDERSENSING, BUT THIS COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION OBTAINED FROM THE CLINICAL SPECIALIST INDICATED THAT THE PHYSICIAN HAS NOT REPORTED ANY FURTHER ISSUES WITH THE PATIENT. THE DEVICE REMAINS IN USE. NO 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. | E2DR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | 5034 IMPLANTABLE PACING LEAD| 4068 IMPLANTABLE PACING LEAD |