FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1792652
·
Received August 11, 2010
Report
- Report Number
- 2182208-2010-00440
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DRB
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
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. CORRECTION: ADDED 2ND STYLET. EVALUATION SUMMARY: NO ANOMALIES FOUND ON BOTH STYLETS.
Description of Event or Problem · 1
IT WAS REPORTED DURING THE IMPLANT PROCEDURE THAT 2 OF THE STYLETS DID NOT MAINTAIN THE "J" SHAPE ONCE PASSED THROUGH THE LEAD, MAKING ATRIAL LEAD PLACEMENT DIFFICULT. ANOTHER STYLET WAS UTILIZED AND THE CASE COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE.
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 | 69 YR | Required Intervention | D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |