FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3052593
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04193
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Additional Manufacturer Narrative · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD NOTED A SUDDEN INCREASE IN SHOCK IMPEDANCE MEASUREMENTS. WHILE INVESTIGATING THE LEAD, T-WAVE OVERSENSING WAS NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155299 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | GUIDANT PUERTO RICO BV | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |