FDA Adverse Event
Injury
Summary report: N
SPECTRAX SX
MDR report key: 1860920
·
Received October 7, 2010
Report
- Report Number
- 2647346-2010-00609
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- July 16, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- K791181/A/B
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 THE DEVICE WAS PACING AT LESS THAN THE PROGRAMMED LOWER RATE. DEVICE WAS 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 | SPECTRAX SX | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | 5985 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | (B)(4) IMPLANTABLE PACING LEAD |