FDA Adverse Event
Injury
Summary report: N
MAXIMO II CRT-D
MDR report key: 3863121
·
Received June 10, 2014
Report
- Report Number
- 9614453-2014-01318
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 9, 2014
- Report Date
- April 9, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. THE LONGEVITY CALCULATION EQUALS 38%.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A PREMATURE DEPLETION IN ABOUT 14 MONTHS. IT WAS ALSO REPORTED THAT DURING THE DEVICE CHANGEOUT, AN XRAY SHOWED THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. THE DEVICE WAS REMOVED AND REPLACED. THE LV LEAD WAS CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 339986 | MAXIMO II CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D284TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Hospitalization| R | 4193 LEAD |