FDA Adverse Event
Malfunction
Summary report: N
MAXIMO II DR
MDR report key: 1792376
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03230
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- May 4, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
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.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT "I WAS CARRYING A BAG WHEN I FELT A SHOCK TO MY LOWER HEART, ALOMOST LIKE A STATIC SHOCK, IT WAS REAL QUICK. I HAD SOMETHING SIMILAR HAPPEN BEFORE WHEN I WAS WALKING UP AN DOWN MY STAIRS. I WASN'T CARRYING ANYTHING THAT FIRST TIME." THE PATIENT WAS ADVISED TO CONTACT HER PHYSICIAN. THE DEVICE REMAINS IMPLANTED AND ACTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO II DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D284DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |