FDA Adverse Event
Injury
Summary report: N
MAXIMO II CRT-D
MDR report key: 3991355
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01710
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 9, 2014
- Report Date
- May 9, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Removal / Correction Number
- Z-0112-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION AND ANALYSIS IS PENDING. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. 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 |
|---|---|---|---|---|---|---|---|
| 467547 | MAXIMO II CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D284TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| R |