FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 1013571
·
Received March 10, 2008
Report
- Report Number
- 2649622-2008-00850
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- August 18, 2005
- Report Date
- June 11, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- Z-0067-007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE LEAD ALSO HAD NON-PHYSIOLOGICAL SENSED EVENTS/NOISE. THE LEAD WAS NOTED TO BE CLEARLY DAMAGED. FURTHER INFORMATION INDICATED THAT THE PATIENT IS PART OF A LAWSUIT ALLEGING THAT THE LEAD IS INHERENTLY DEFECTIVE AND THAT THE PATIENT MAY HAVE SUFFERED DAMAGES AND LOSSES INCLUDING, BUT NOT LIMITED TO: EMOTIONAL DISTRESS, INCLUDING MENTAL DISTRESS, ANGER, DEPRESSION AND ANXIETY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO, INC. | 6949 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR | Hospitalization| R| R |