FDA Adverse Event
Malfunction
Summary report: N
TBD
MDR report key: 3151904
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05595
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- January 31, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE DEFIB LEAD 2003 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. THE LV 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 |
|---|---|---|---|---|---|---|---|
| 253296 | TBD | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | (B)(4) IMPLANTABLE BIV DEFIBRILLATOR |