FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1945068
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-20772
- Event Type
- Malfunction
- Date Received
- January 3, 2011
- Date of Event
- October 5, 2010
- Report Date
- October 5, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO INTEVENTION HAS BEEN PERFORMED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED INCREASED MONITORING OF THE PATIENT. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD A PACING IMPEDANCE MEASUREMENT OF 2400 OHMS. IT WAS REPORTED THE IMPEDANCE MEASUREMENT HAD BEEN INCREASING SINCE IMPLANT. NO OTHER MEASUREMENTS WERE REPORTED TO BE OUT OF RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | H230| 0175| 4542| 4548 |