FDA Adverse Event
Injury
Summary report: N
INSYNC MAXIMO
MDR report key: 3152054
·
Received June 7, 2013
Report
- Report Number
- 3004209178-2013-08793
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD: (B)(6) 2005. 5071-35 IMPLANTABLE PACING LEAD: (B)(6) 2005. (B)(4). EVALUATION SUMMARY: UPON ANALYSIS, NO ANOMALIES FOUND.
Description of Event or Problem · 1
THE PATIENT REPORTED BELIEVING THAT RADIATION FROM THE DEVICE MAY HAVE RESULTED IN THE LOSS OF THE PATIENT'S TEETH. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252107 | INSYNC MAXIMO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Hospitalization| R | 694965 IMPLANTABLE TACHY LEAD |