FDA Adverse Event
Malfunction
Summary report: N
PROTECTA XT DR
MDR report key: 3051020
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05908
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Report Date
- February 25, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
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: 4592 IMPLANTABLE PACING LEAD - 2012 (B)(6). (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH AROUND THE DEVICE POCKET, AND AN ALLERGY TEST DETERMINED THAT THE PATIENT WAS ALLERGIC TO NICKEL. PER FOLLOW UP, IT IS UNKNOWN WHETHER OR NOT THE DEVICE WILL BE EXPLANTED AT THIS TIME. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153343 | PROTECTA XT DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D314DRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6947M IMPLANTABLE TACHY LEAD |