FDA Adverse Event
Injury
Summary report: N
ENPULSE
MDR report key: 2134009
·
Received June 20, 2011
Report
- Report Number
- 6000144-2011-03238
- Event Type
- Injury
- Date Received
- June 20, 2011
- Date of Event
- April 19, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S032
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PULSE GENERATOR CHANGE THE MONITOR SHOWED A HEART RATE OF 30, SLOW ATRIAL FIBRILLATION AND NO PACING. THE GENERATOR WAS REMOVED AND REPLACED. 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. | E2DR21 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| L| R | 5024M IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) HEART RING |