FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210116
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07234
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- March 11, 2013
- Report Date
- April 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE PACING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. UPON EXPLANT OF THIS DEVICE, WHAT LOOKED TO BE LIQUID WAS FOUND IN THE DEVICE HEADER WHICH MIGHT HAVE LEAD TO IRREGULAR VOLTAGE READINGS. BOTH THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310800 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| L| R | N164| H179| 0158| 4088| T180| 4518 |