FDA Adverse Event
Malfunction
Summary report: N
MAXIMO DR
MDR report key: 2130129
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03313
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 3, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S37
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. EVALUATION SUMMARY (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THIS DATA SHOWED POWER ON RESET (POR) PARAMETERS FOR WRITE TO LOCKED RAM ON (B)(6) 2011 01:17:05, AND A PATIENT ALERT FOR POR ON (B)(6) 2011 00:17:05.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CLINICIAN NOTICED AN ELECTRICAL RESET OF THE DEVICE ON A MONITOR TRANSMISSION. 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 DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7278 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD |