FDA Adverse Event
Malfunction
Summary report: N
MAXIMO II DR
MDR report key: 2131955
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03517
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE DEVICE WAS STARTING TO FAIL. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE PATIENT CONTACTED THE OFFICE REGARDING A FINANCIAL BILL, BUT THAT THERE WAS NO COMPLAINT ABOUT THE PERFORMANCE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 | 60 YR | Other | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |