FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 4162337
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02530
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 26, 2014
- Report Date
- August 26, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT MEDICAL PRODUCTS: A 6947-58 LEAD, IMPLANTED: (B)(6) 2007. A 4549 BOSTON SCIENTIFIC LEAD, IMPLANTED: (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) IN LESS THAN FOUR YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639417 | CONSULTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| R | 5076-45 LEAD |