FDA Adverse Event
Injury
Summary report: N
MAXIMO II DR
MDR report key: 2811514
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06524
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- November 19, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Adverse Event
- Yes
- 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.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE HAD TANTALUM CAPACITOR LEAKAGE UNSPECIFIED.
Description of Event or Problem · 1
IT WAS NOTED THAT THERE WAS HIGH IMPEDANCE ON BOTH THE ATRIAL AND VENTRICULAR LEADS. SINCE IT COULD NOT DETERMINED IF THIS WAS A LEAD OR DEVICE PROBLEM, THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO II DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL, INC. | D284DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |