FDA Adverse Event
Injury
Summary report: N
MAXIMO VR
MDR report key: 3160415
·
Received June 10, 2013
Report
- Report Number
- 3004209178-2013-10085
- Event Type
- Injury
- Date Received
- June 10, 2013
- Date of Event
- April 6, 2013
- Report Date
- April 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. 6996 IMPLANTABLE PACING LEAD IMPLANTED: 2006 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN WAS SHOCKED DURING SURGERY. MAGNET WAS PLACED OVER THE DEVICE DURING THE SURGERY. THE DEVICE REMAINS IN USE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260275 | MAXIMO VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7232CX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Life Threatening| R | 6947 IMPLANTABLE TACHY LEAD |