FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 1072252
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03896
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- March 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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.
Description of Event or Problem · 1
IT WAS REPORTED THE PACE/SENSE PORTION OF THE 6944 LEAD WAS CAPPED AND THE HV PORTION REMAINED IN USE DUE TO SENSING DIFFICULTY, FRACTURE AND INAPPROPRIATE THERAPY. 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 QUATTRO | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Hospitalization| R | 7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |