FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1870923
·
Received October 15, 2010
Report
- Report Number
- 2124215-2010-17188
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- August 25, 2010
- Report Date
- August 25, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A PERFORATION. THE PATIENT BECAME HYPOTENSION AND DID NOT RESPOND TO FLUIDS OR MEDICATION. AN ECHOCARDIOGRAM NOTED PERICARDIAL FLUID BUILDUP. A PERICARDIOCENTESIS WAS PERFORMED AND DURING THE PROCEDURE, THE NEEDLE PERFORATED THE SIDE OF THE PERICARDIAL SAC AND PERFORATED THE BOWEL. THE PATIENT HAS STABILIZED AND IS RECOVERING. IT WAS UNCLEAR WHICH LEAD CAUSED THE ORIGINAL PERFORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Life Threatening | 4086| 4087| S403 |