MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-15 for ASKU MEDT/PROGRAMMER manufactured by Medtronic, Inc..
[2205376]
Asku
Patient Sequence No: 1, Text Type: D, B5
[9149000]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[19873062]
It was reported that the programmer was indicating an error. A service disc will be used to correct the error. No patient complications have been reported as a result of this event. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[19942998]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2011-00809 |
| MDR Report Key | 2128108 |
| Report Source | 07 |
| Date Received | 2011-06-15 |
| Date of Event | 2011-04-07 |
| Date Mfgr Received | 2011-04-07 |
| Device Manufacturer Date | 2002-11-26 |
| Date Added to Maude | 2011-10-14 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHAD HEDLUND SR VIGILANCE COMPLIANCE MGR |
| Manufacturer Street | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635149619 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | ASKU |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASKU |
| Generic Name | PROGRAMMER |
| Product Code | JOQ |
| Date Received | 2011-06-15 |
| Model Number | MEDT/PROGRAMMER |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | ASKU |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-15 |