FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 2790579
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14430
- Event Type
- Injury
- Date Received
- October 15, 2012
- Report Date
- August 13, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD MIGRATED. IT WAS ALSO REPORTED THAT THE PATIENT COULD FEEL THE POINT OF MAXIMAL IMPULSE OF THE HEART AND REQUESTED THAT THE RIGHT VENTRICULAR [RV] LEAD BE REPOSITIONED AS WELL. THE DEVICE WAS REPOSITIONED AND REMAINS IN USE; THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED "SHOCKS" FROM THE RV LEAD IN THE WEEKS PRIOR TO THE PROCEDURE TO REPOSITION THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Hospitalization| R |