FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 1013438
·
Received March 10, 2008
Report
- Report Number
- 2649622-2008-00914
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- October 30, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- Z-0067-007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED, OUTER TUBING OVERLAY MELTED, BLOOD/BODY FLUID ON OUTER TUBING OVERLAY, AND BLOOD NOTED ON HELIX MECHANISM; FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
THE LEAD WAS RETURNED AND ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. A LAWSUIT ALLEGED THAT THE PATIENT SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD, AND THAT THE PATIENT "EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, FRACTURE OR OTHER INJURY REQUIRING MEDICAL INTERVENTION." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6949 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D153VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |