FDA Adverse Event
Injury
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 3152289
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06879
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 29, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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: D334TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2013; 4194 IMPLANTABLE PACING LEAD (B)(6) 2007; 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS NOTED ON THE RIGHT VENTRICULAR LEAD ONE DAY POST IMPLANT. THE LEAD AND SET SCREWS WERE RECONNECTED. BOTH THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252969 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| R |