FDA Adverse Event
Malfunction
Summary report: N
PUNCTUA
MDR report key: 2780508
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-13098
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 11, 2012
- Report Date
- September 11, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, A FEW WEEKS AFTER IMPLANT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH OUT OF RANGE (OOR) PACING IMPEDANCE MEASUREMENTS IN THE RIGHT ATRIUM (RA). THE RA LEAD IS A COMPETITOR PRODUCT. THE PATIENT REMAINS IN THE HOSPITAL, AND THE DEVICE WILL BE REPROGRAMMED WITHIN THE NEAR FUTURE. SUBSEQUENTLY, THIS ICD WAS REPROGRAMMED TO VVI, AND AN RA LEAD REVISION WILL TAKE PLACE AT A FUTURE DATE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUNCTUA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |