FDA Adverse Event
Injury
Summary report: N
SPECTRAFLEX
MDR report key: 3152576
·
Received June 7, 2013
Report
- Report Number
- 6000023-2013-00019
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MEDTRONIC, B.V.
- Product Code
- DTB
- PMA / PMN Number
- K790429
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW THRESHOLD. IT WAS ALSO REPORTED THAT PROGRAMMED VOLTAGE WHAT INCREASED, HOWEVER THAT CREATED SOME POCKET STIMULATION. THEREFORE VENTRICULAR CAPTURE MANAGEMENT (VCM) WAS PROGRAMMED OFF AND PROGRAMMED VOLTAGE ADJUSTED STILL LEAVING A GOOD SAFETY MARGIN FOR THE PATIENT WITH HIGH THRESHOLD. THE RV LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 252083 | SPECTRAFLEX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC, B.V. | 6957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | Life Threatening| R | ADSR06 IMPLANTABLE PACEMAKER |