FDA Adverse Event
Injury
Summary report: N
INSYNC MAXIMO
MDR report key: 1072419
·
Received July 10, 2008
Report
- Report Number
- 6000144-2008-00160
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- March 28, 2008
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND THE BATTERY DEPLETION WAS NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCE READINGS ON THE RIGHT AND LEFT VENTRICULAR LEADS. IMPEDANCE READINGS WERE ACCEPTABLE WHEN CHECKED WITH A DIFFERENT DEVICE AND WITH AN ANALYZER. THE DEVICE WAS REPLACED. THE DEVICE WAS RETURNED WITH NO INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC MAXIMO | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | 7303 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | 4194 IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 5524M IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |