FDA Adverse Event
Injury
Summary report: N
ENPULSE
MDR report key: 1862894
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-05030
- Event Type
- Injury
- Date Received
- October 9, 2010
- Date of Event
- July 21, 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 VENTRICULAR CAPTURE MANAGEMENT WAS TURNED OFF BECAUSE THE PATIENT HAD DIAPHRAMMATIC STIMULATION. THE VCM THRESHOLD HAD GONE FROM 0.875V AT 0.4MS TO 5V AT 1MS. THE PATIENT IS NOT PACEMAKER DEPENDENT. THE DEVICE REMAINS 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 | ENPULSE | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | E2DR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | COMPETITOR-2 IMPLANTABLE PACING LEAD| COMPETITOR-1 IMPLANTABLE PACING LEAD |