MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-06 for PACEART OPTIMA POS12D15 manufactured by Medtronic, Inc..
[56944624]
Patient Sequence No: 1, Text Type: N, H10
[56944625]
It was reported that the patient management database application displayed implantable cardiac monitor (icm) data as asystole when the data actually indicated pauses when importing the data from a flash drive. The issue was escalated for investigation. The application remains in use. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[72916935]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2182208-2016-02480 |
MDR Report Key | 6009063 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2016-10-06 |
Date of Report | 2016-08-11 |
Date of Event | 2016-08-11 |
Date Mfgr Received | 2016-08-11 |
Date Added to Maude | 2016-10-06 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | ANNE SCHILLING |
Manufacturer Street | 8200 CORAL SEA ST NE |
Manufacturer City | MOUNDS VIEW MN 55112 |
Manufacturer Country | US |
Manufacturer Postal | 55112 |
Manufacturer Phone | 7635052036 |
Manufacturer G1 | MEDTRONIC, INC. |
Manufacturer Street | 8200 CORAL SEA STREET NE |
Manufacturer City | MOUNDS VIEW MN 55112 |
Manufacturer Country | US |
Manufacturer Postal Code | 55112 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PACEART OPTIMA |
Generic Name | ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT |
Product Code | KRE |
Date Received | 2016-10-06 |
Model Number | POS12D15 |
Catalog Number | POS12D15 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC, INC. |
Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2016-10-06 |