FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO
MDR report key: 1791532
·
Received August 10, 2010
Report
- Report Number
- 2649622-2010-06977
- Event Type
- Malfunction
- Date Received
- August 10, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 IMPEDANCE IS IN THE 2900 OHM RANGE AND HAS BEEN GRADUALLY INCREASING SINCE 2005. THE PATIENT WAS NOT SEEN BETWEEN (B)(6) 2008 UNTIL (B)(6) 2009. THE PATIENT ALERT WAS TRIPPED IN (B)(6) 2010 FOR AN IMPEDANCE GREATER THAN 3000 OHMS. NO 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 | 33 YR | Other | 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |