FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 1013566
·
Received March 10, 2008
Report
- Report Number
- 2649622-2008-00856
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- April 4, 2006
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
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). THE PROXIMAL SEGMENT WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS OBSERVED ON SEVERAL CONDUCTORS. THE DISTAL, DEFIBRILLATION AND PROXIMAL CONDUCTORS WERE FRACTURED. THE DISTAL CONDUCTOR WAS DISTORTED. THE OUTER INSULATION WAS BREACHED/CUT, HAD A COSMETIC DEPRESSION AND A WHITE SUBSTANCE WAS OBSERVED. THE INNER TUBING HAD A BREACHED DEPRESSION. THE LEAD WAS FLEXED WITHIN 5CM OF THE ANCHORING SLEEVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6932 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | 7223 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 7223 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 7223 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |