FDA Adverse Event
Injury
Summary report: N
QUICKFLEX XL LV LEAD
MDR report key: 1896156
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04849
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 19, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
ON (B)(6) 2010, BLEEDING WAS NOTED ON THE LEFT CHEST AT THE OLD SITE REMOVAL AND ON THE RIGHT CHEST AT THE NEW IMPLANT SITE. ON (B)(6) 2010, A HEMATOMA WAS NOTED AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH KEFLEX AND MONITORED; THE HEMATOMA RESOLVED BY (B)(6) 2010. ON 2010, THE PATIENT PRESENTED DUE TO DIAPHRAGMATIC STIMULATION HE HAD BEEN EXPERIENCING SINCE 2010. THE LEAD EXHIBITED LOSS OF CAPTURE. A CHEST X-RAY FOUND THAT THE LEAD HAD DISLODGED. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKFLEX XL LV LEAD | PERMANENT PACEMAKER ELECTRODE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1158T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |