FDA Adverse Event
Injury
Summary report: N
DISCOVERY II
MDR report key: 1945554
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20026
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 13, 2010
- Report Date
- October 13, 2010
- Manufacturer
- GUIDANT CLONMEL IRELAND
- Product Code
- NVZ
- Removal / Correction Number
- Z-875/897-03
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER EMITTED NO MAGNET RESPONSE. ELECTROGRAM REVIEW REVEALED SECOND DEGREE HEART BLOCK AND NO PACING WAS VISIBLE. THIS DEVICE WAS IMPLANTED IN 2002 AND WAS REPORTED TO HAVE REACHED END OF LIFE (EOL). NO CHANGES HAVE BEEN PERFORMED ON THIS SYSTEM AND CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISCOVERY II | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CLONMEL IRELAND | 1283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | 4470| 4457| 1283 |