FDA Adverse Event
Malfunction
Summary report: N
PROTECTA XT CRT-D
MDR report key: 3862167
·
Received June 10, 2014
Report
- Report Number
- 9614453-2014-01399
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 2, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 PRODUCT: 7121 LEAD (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS APPROACHING BATTERY REPLACEMENT TIME. THE BATTERY LONGEVITY OF THE DEVICE WAS LESS THAN EXPECTED. IT WAS NOTED THAT THE DEVICE IS NOT IN ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338855 | PROTECTA XT CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D314TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | 4076-58 LEAD, 4193-88 LEAD |