FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 1990410
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-01971
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THAT THE RIGHT VENTRICLE AND SUPERIOR VENA CAVA IMPEDANCES HAVE SPIKED TO 150 OHMS. THE PHYSICIAN DECIDED TO EXTRACT THE LEAD. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 | 63 YR | Hospitalization| R | 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| COMPETITOR IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |