FDA Adverse Event
Malfunction
Summary report: N
INGENIO
MDR report key: 2780456
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-13484
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 14, 2012
- Report Date
- September 14, 2012
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVZ
- 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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT 6 MONTHS AFTER IMPLANT, THIS DEVICE STATED 6 YEARS REMAINING LONGEVITY WITH AND A CURRENT DRAIN OF 119% USAGE FOR THE DEVICE SETTINGS. THE DEPLETION RATE OF THE DEVICE WAS THEREFORE QUESTIONS BY THE PHYSICIAN. A MEMORY DUMP WAS SUGGESTED HOWEVER WITH CURRENT INFORMATION HAS NOT YET TAKEN PLACE. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT INFORMATION COULD BE OBTAINED FROM A FIELD REPRESENTATIVE. NO ADVERSE PATIENT EFFECTS OR REMEDIAL ACTION WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INGENIO | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT PUERTO RICO BV | K173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |