FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 2965098
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01585
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- December 30, 2009
- Report Date
- February 8, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4) IMPLANTABLE PACING LEAD (B)(6) 2007, (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2007.
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 REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. IT WAS NOTED THAT THE SUTURES HAD BECOME LOOSE AND THE LEAD HAD NO SLACK AND WAS IN THE RIGHT ATRIUM. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67845 | SPRINT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | RICE CREEK MFG | 6943-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |