FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX
MDR report key: 1862890
·
Received October 9, 2010
Report
- Report Number
- 2649622-2010-10485
- Event Type
- Injury
- Date Received
- October 9, 2010
- Date of Event
- July 16, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P060039
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. FULL LEAD WAS RETURNED AND ANALYZED. DISTAL CONDUCTOR BLOOD, HELIX DISTORTED, BLOOD/BODY FLUID OUTER TUBING OVERLAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO IMPLANT THE LEAD. WHEN THE TARGET VESSEL WAS REACHED, THEY FOUND THERE WAS MUSCLE STIMULATION. THE LEAD WAS REMOVED AND RETURNED. A NEW LEAD WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS 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 | 81 YR | Required Intervention |