FDA Adverse Event
Malfunction
Summary report: N
MAXIMO II DR
MDR report key: 1920657
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05639
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- September 2, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 THEY FELT "BURNING" AND "SORENESS" NEAR THE DEVICE IMPLANT SITE. THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
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 | 32 YR | Other | 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD |