FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 2171226
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10215
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- March 24, 2011
- Report Date
- June 6, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS ACTIVELY IMPLANTED. 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 LEFT VENTRICULAR (LV) LEAD WAS BECAME DISLODGED BECAUSE THE PATIENT WAS A TWIDDLER AND PULLED THE LEAD INTO THE POCKET. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE HF LEAD | OJX | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Life Threatening| R | H120| 4542| 4592| 4088| 4470 |