FDA Adverse Event
Malfunction
Summary report: N
EXTENSION PASSER ASSESSORY KIT
MDR report key: 1032606
·
Received April 22, 2008
Report
- Report Number
- 2182207-2008-02125
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- February 29, 2008
- Report Date
- March 24, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- CLASS I EXEM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OTHER: SURGICAL INCISION, ADDITIONAL.
Description of Event or Problem · 1
IT WAS REPORTED THE CARRIER SNAPPED DURING THE TUNNELING PROCEDURE. THE SURGEON WAS REQUIRED TO MAKE AN ADDITIONAL INCISION. THE CARRIER SNAPPED AT THE JUNCTION OF THE NARROW WITH THE LARGER DIAMETER PORTION. NO OTHER PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTENSION PASSER ASSESSORY KIT | LGW/MHY | LGW | MEDTRONIC NEUROMODULATION | 3655 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| EXTENSION MODEL 7482A| IMPLANTED |