FINELINE I
Report
- Report Number
- 2124215-2013-04695
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 19, 2013
- Report Date
- May 2, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED SEVERED. VISUAL INSPECTION REVEALED SETSCREW MARKS NOTED ON THE TERMINAL PIN AND TERMINAL RING. THE LEAD WAS TESTED AND SHOWED TO BE ELECTRICALLY CONTINUOUS AND NO LEAD FRACTURE WAS CONFIRMED. LABORATORY ANALYSIS COULD NOT CONFIRMED THE REPORTED CLINICAL OBSERVATION.
ADDITIONAL INFORMATION WAS RECIEVED WHICH NOTED THAT THIS LEAD WAS EXPLANTED AND WILL BE RETURNED. UPON ANLAYSIS THIS INVESTIGATION WILL BE UPDATED.
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BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP IT WAS NOTED THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE PACING IMPEDANCES. IN ADDITION, HIGH THRESHOLDS RESULTING LOSS OF CAPTURE WERE NOTED. A LEAD FRACTURE WAS SUSPECTED. THE PACE/SENSE PORTION OF THIS RIGHT VENTRICULAR LEAD WAS DEACTIVATED AND WAS PROGRAMMED TO LEFT VENTRICULAR PACING ONLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155183 | FINELINE I | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| L | 1241| 4451| 4512| 4461| H145 |