FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 3041111
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01538
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 9, 2013
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE RATE\SENSE PORTION WHICH RESULTED IN OVERSENSING AND PACING INHIBITION GREATER THAN TWO SECONDS. THE PACING INHIBITION WAS NOT A FACTOR DUE TO THE INTRINSIC RATE OF 60 BEATS PER MINUTE (BPM) AND THE DEVICE PROGRAMMING OF DUAL CHAMBER SENSING AND PACING AND RESPONSE. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144083 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | HISTORICAL PUERTO RICO | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| L| R | T165| 1488K| 1861| 1762| 0125 |