FDA Adverse Event
Malfunction
Summary report: N
DISCOVERY II
MDR report key: 2522469
·
Received April 9, 2012
Report
- Report Number
- 2124215-2012-03327
- Event Type
- Malfunction
- Date Received
- April 9, 2012
- Date of Event
- February 15, 2012
- Report Date
- February 22, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. 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 PACEMAKER HAD A MAGNET RATE OF 100 PACES PER MINUTE (PPM) HOWEVER THE REMAINING LONGEVITY DISPLAYED WAS LESS THAN .5 YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED MAGNET RATES AND THE ELECTIVE REPLACEMENT TIME (ERT) TO END OF LIFE (EOL) TIMEFRAME. IT WAS REPORTED THE PATIENT WAS EXPERIENCING FATIGUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISCOVERY II | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | 4135| 4136| 1286| 4086| 4034 |