FDA Adverse Event
Injury
Summary report: N
ENPULSE
MDR report key: 1792499
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03276
- Event Type
- Injury
- Date Received
- August 11, 2010
- Date of Event
- May 6, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S032
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 CAPTURE THRESHOLDS AND IMPEDANCE WERE HIGH. ADDITIONALLY, THERE WAS POCKET STIMULATION. THE VENTRICULAR LEAD AND PULSE GENERATOR WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS 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 | 78 YR | Required Intervention | 4058M IMPLANTABLE PACING LEAD |