FDA Adverse Event
Injury
Summary report: N
PROTECTA XT DR
MDR report key: 3151870
·
Received June 7, 2013
Report
- Report Number
- 3004209178-2013-08808
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- February 9, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 MEDICAL PRODUCTS: 0158, COMPETITOR IMPLANTABLE DEFIBRILLATION LEAD: IMPLANTED (B)(6) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR POCKET HEMATOMA. BLOOD WAS DRAINING FROM THE INCISION SITE TWO DAYS POST-IMPLANT. THE POCKET WAS REVISED AND THE EVENT CONSIDERED RESOLVED SIX DAYS POST-IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253261 | PROTECTA XT DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D314DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00092 YR | Hospitalization| R | 4470, COMPETITOR IMPLANTABLE PACING LEAD |