FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1922466
·
Received December 13, 2010
Report
- Report Number
- 2182208-2010-00949
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DRB
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: STYLET THE STYLET WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE STYLET WAS BENT AND APPEARED TO BE DAMAGED AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STYLET SEEMED TO BE THIN AT THE DISTAL END AND WOULD NOT HOLD THE LEAD IN A J POSITION. THE STYLET WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | STYLET | DRB | MEDTRONIC, INC. | STYLET | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |