MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-12 for NONE 080118 manufactured by Medtronic, Inc..
[16423668]
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
[16582316]
It was reported that an infection occurred. The leads were explanted and replaced. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2011-02995 |
| MDR Report Key | 2368521 |
| Report Source | 07 |
| Date Received | 2011-12-12 |
| Date of Event | 2011-03-11 |
| Date Mfgr Received | 2011-09-08 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2011-12-12 |
| 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 | NONE |
| Generic Name | MEDICAL ADHESIVE |
| Product Code | KFJ |
| Date Received | 2011-12-12 |
| Model Number | 080118 |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2011-12-12 |