FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3053575
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05258
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 23, 2006
- Report Date
- March 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT EXPIRED SIX WEEKS AFTER THE INITIAL IMPLANT PROCEDURE (SEVEN YEARS AGO), HOWEVER THE PROXIMAL SEGMENT OF THE LEAD WAS JUST RETURNED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY ONLY THE PROXIMAL SEGMENT OF LEAD WAS RETURNED SEVERED 19.2 CM FROM IS-1 PIN. NO IRREGULARITIES WERE NOTED WITH THE RETURNED PORTION OF THE LEAD.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SEVEN YEARS PRIOR THIS ATRIAL LEAD DISLODGED ONE DAY POST-IMPLANT. THE LEAD WAS SUCCESSFULLY REPOSITIONED THAT SAME DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE REPOSITIONING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155637 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | 4088| 4087| 1296 |