FDA Adverse Event
Malfunction
Summary report: N
ATTAIN STARFIX
MDR report key: 2123836
·
Received June 14, 2011
Report
- Report Number
- 2649622-2011-08014
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- February 25, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P060039
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THE LEAD INTEGRITY ALERT WAS TRIPPED AND THERE WERE SHORT INTERVAL COUNTS ON THE RIGHT VENTRICULAR LEAD. THE LEFT VENTRICULAR LEAD IN NON FUNCTIONING AND IT WAS REPORTED THE STYLET WAS LEFT IN THE LEAD HAS NOW FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN STARFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4195 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |