FDA Adverse Event
Malfunction
Summary report: N
SUBQ
MDR report key: 3920380
·
Received July 8, 2014
Report
- Report Number
- 2182208-2014-01832
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- June 13, 2014
- Report Date
- June 13, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 4968 X2, IMPLANTED (B)(6) 2011; 6996 IMPLANTED (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN ALERT DUE TO FLUCTUATIONS IN THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS. A CHEST X-RAY WAS OBTAINED AND NOTED STRETCHING OF THE RV LEAD. A LEAD FRACTURE IS SUSPECTED. NO CHANGES HAVE BEEN MADE AT THIS TIME AND THE RV LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 397780 | SUBQ | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC, INC. | 6996SQ41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00009 YR | D224DRG ICD |