FDA Adverse Event
Injury
Summary report: N
SPECTRAX SXT
MDR report key: 1990447
·
Received February 15, 2011
Report
- Report Number
- 2647346-2011-00156
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- K810734
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED AND THAT THE DEVICE WAS PACING "ERRATICALLY." THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRAX SXT | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | 8420 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 4012 IMPLANTABLE PACING LEAD| 4012 IMPLANTABLE PACING LEAD |