FDA Adverse Event
Injury
Summary report: N
MAXIMO II CRT-D
MDR report key: 2954438
·
Received February 11, 2013
Report
- Report Number
- 9614453-2013-00454
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. (B)(4). EVALUATION SUMMARY: (B)(4): REVIEW OF PERFORMANCE DATA SHOWED THAT THE DEVICE WAS APPROACHING RRT (RECOMMENDED REPLACEMENT TIME). UPON FULL ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DID NOT REACH EXPECTED LONGEVITY. 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 |
|---|---|---|---|---|---|---|---|
| 58185 | MAXIMO II CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D284TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Hospitalization| R |