PROTECTA CRT-D
Report
- Report Number
- 3004209178-2013-08866
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WAS INTERROGATED AFTER BEING REMOVED FROM THE BOX, AND WAS FOUND TO ALREADY BE AT END OF SERVICE (EOS). IT WAS NOTED THAT THE DEVICE INDICATED HAVING DELIVERED OVER 500 SHOCKS. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WAS INTERROGATED AFTER BEING REMOVED FROM THE BOX, AND WAS FOUND TO ALREADY BE AT END OF SERVICE (EOS). IT WAS NOTED THAT THE DEVICE INDICATED HAVING DELIVERED OVER 500 SHOCKS. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258231 | PROTECTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D334TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR |