FDA Adverse Event
Injury
Summary report: N
PROTECTA XT CRT-D
MDR report key: 2813338
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06145
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 12, 2012
- Report Date
- December 17, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031/S171
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INFECTION OCCURRED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SEPSIS. THE DEVICE AND LEADS WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT INFECTION OCCURRED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SEPSIS. THE DEVICE AND LEADS WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTECTA XT CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D314TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R |