FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 1864872
·
Received October 12, 2010
Report
- Report Number
- 2649622-2010-10913
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- August 2, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN ATRIAL THRESHOLD SINCE IMPLANT. THE NURSE THINKS THAT THE PATIENT'S USE OF A CANE WITH HIS LEFT (PACEMAKER) ARM MAY HAVE CAUSED SOME STRESS ON THE LEAD. THE LEAD IS STILL 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 | ASKU | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | LEAD/MEDT | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |