FDA Adverse Event
Injury
Summary report: N
MAXIMO II CRT-D
MDR report key: 2864775
·
Received December 10, 2012
Report
- Report Number
- 3004209178-2012-11412
- Event Type
- Injury
- Date Received
- December 10, 2012
- Report Date
- September 11, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE DID NOT MEET THE EXPECTED LONGEVITY. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. 5076 IMPLANTABLE PACING LEAD 2009 (B)(6); 6947 IMPLANTABLE TACHY LEAD 2009 (B)(6). (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS REPLACED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO II CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D284TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR | Hospitalization| R | 4194 IMPLANTABLE PACING LEAD |