FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3210982
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08247
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- March 28, 2013
- Report Date
- June 10, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310601 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization | 4087| 4088| K173 |