FDA Adverse Event
Injury
Summary report: N
REPLY DR
MDR report key: 2061581
·
Received April 18, 2011
Report
- Report Number
- 2182863-2011-00030
- Event Type
- Injury
- Date Received
- April 18, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 21, 2011
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APRIL 18, 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.
Additional Manufacturer Narrative · 1
(B)(4), 2011. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4), 2011.
Description of Event or Problem · 1
ONE DAY POST IMPLANT, THE IMPEDANCE WAS AROUND 210 OHMS IN BIPOLAR WITH FAILURE TO SENSE OR CAPTURE. AN INTERVENTION WAS PERFORMED AND THE VENTRICULAR OSCOR LEAD WAS FOUND TO HAVE AN INSULATION BREAK. THE LEAD WAS REPLACED ALONG WITH THIS PACEMAKER SINCE A NEW PACEMAKER BOX HAD BEEN OPENED.
Description of Event or Problem · 1
ONE DAY POST IMPLANT, THE IMPEDANCE WAS AROUND 210 OHMS IN BIPOLAR WITH FAILURE TO SENSE OR CAPTURE. AN INTERVENTION WAS PERFORMED AND THE VENTRICULAR OSCOR LEAD WAS FOUND TO HAVE AN INSULATION BREAK. THE LEAD WAS REPLACED ALONG WITH THIS PACEMAKER SINCE A NEW PACEMAKER BOX HAD BEEN OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY DR | CARDIAC PACEMAKER | DXY | SORIN BIOMEDICA CRM S.R.L. | REPLY DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |