CAPSUREFIX
Report
- Report Number
- 2649622-2011-02954
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S2
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PROXIMAL CONDUCTOR HAD BLOOD/BLOODY FLUID (NOT OBSTRUCTED); OUTER INSULATION KINKED/BUCKLED, HAD A BREACHED CUT AND COSMETIC DEPRESSION; BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS STRETCHED AND HAD APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. OUTER INSULATION BREACHED DEPRESSION. PROXIMAL CONDUCTOR STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); OUTER INSULATION KINKED/BUCKLED; OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION. THE HELIX/LOBE WAS DISTORTED/BENT; BLOOD IN/ON HELIX/LOBE MECHANISM. THE LEAD WAS STRETCHED.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC AND POCKET STIMULATION FROM THE RIGHT ATRIAL (RA) LEAD. THE LEAD "HAS SHOWN SIGNS OF FRACTURE". THE RA LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE RIGHT VENTRICULAR LEAD WAS RETURNED, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5568 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Hospitalization| R | E2DR21 IMPLANTABLE PULSE GENERATOR |