FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2053025
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04063
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- January 28, 2011
- Report Date
- March 14, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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.
Additional Manufacturer Narrative · 1
IT WAS LATER REPORTED THAT UPON A DEVICE INTERROGATION THE MESSAGE NOTED TO CHECK THE LEFT VENTRICULAR LEAD. THE PATIENT DID REPORTED STIMULATION AND HAD THEIR DEVICE REPROGRAMMED THE WEEK BEFORE. THE PACING IMPEDANCES ON THIS LEAD HAD BEEN 1690 OHMS AT IMPLANT BUT HAD BEEN GRADUALLY DECLINING TO 566 OHMS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE THIS LEFT VENTRICULAR LEAD MEASURED 2000 OHMS. THE LEAD WAS RECONNECTED AND TESTED AND MEASURED 1952 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | 0185| 4555| N119| T175| (B)(4) |