FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 1992591
·
Received February 15, 2011
Report
- Report Number
- 2182208-2011-00197
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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
A PHYSICIAN REPORTED "LOSS OF DDDR OR VVIR PACING IN ACTIVE PACEMAKER DEPENDENT PATIENTS SOMETIMES LEADS TO SIGNIFICANT FUNCTIONAL LIMITATIONS. WHEN LOSS OF RATE RESPONSIVE PACING LEADS TO WORK RELATED LIMITATIONS WE FIND OURSELVES URGENTLY SCHEDULING WHAT SHOULD IDEALLY HAVE BEEN AN ELECTIVE SURGERY." FOLLOW-UP WILL BE ATTEMPTED TO DETERMINE IF MORE SPECIFIC INFORMATION IS AVAILABLE. 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 PULSE GENERATOR | NVZ | MEDTRONIC, INC. | IPG/MEDT | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |