FDA Adverse Event
Other
Summary report: N
SETROX S 53
MDR report key: 2040199
·
Received March 25, 2011
Report
- Report Number
- 1028232-2011-00678
- Event Type
- Other
- Date Received
- March 25, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 15, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DISLODGEMENT WITHOUT INTERVENTION.
Description of Event or Problem · 1
LEAD DISLODGEMENT WAS SUSPECTED. A HOME MONITORING REPORT WAS REVIEWED BY (B)(6) CLINIC ON (B)(6) 2011 REVEALING PROPER SYSTEM FUNCTION. REVIEW OF THE ELECTROGRAMS SHOWED NOISE ON THIS ATRIAL LEAD THAT RESULTED IN DEVICE MODE SWITCHING. LEAD IMPEDANCE TRENDS WERE NOTED AS STABLE. THE PT WAS SUBSEQUENTLY BROUGHT INTO THE CLINIC ON (B)(6) 2011 AND NOISE WAS REPRODUCIBLE WITH MYOPOTENTIALS. CAPTURE AND SENSING WERE NOTED TO BE WITHIN NORMAL RANGES. AT THIS TIME, THE TYPE OF INTERVENTION PERFORMED, IF ANY, IS UNK. NO ADDITIONAL INFO IS AVAILABLE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 53 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG | 350974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |