FDA Adverse Event
Malfunction
Summary report: N
INCEPTA
MDR report key: 3955869
·
Received July 24, 2014
Report
- Report Number
- 2124215-2014-14453
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES GREATER THAN 2000 OHMS ALONG WITH NOISE. THE PHYSICIAN BELIEVES THIS MAY BE ATTRIBUTED TO A CONNECTION OR SETSCREW ISSUE, BUT SINCE THE PATIENT IS NOT DEPENDANT ON ATRIAL PACING, THERE ARE NO PLANS TO INTERVENE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433767 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | 0296| 4087| E162 |