MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-02-13 for TRIUMPH VR 1124 manufactured by Rice Creek Mfg.
[10334420]
.
Patient Sequence No: 1, Text Type: N, H10
[10771897]
Product event summary: the device was returned and no analysis was completed and the device is a competitor product.
Patient Sequence No: 1, Text Type: N, H10
[20796154]
It was reported that during a routine explant procedure, difficulties were encountered with removing the chronic right ventricular lead from the header of the device. The physician used mineral oil and saline to aid in the removal of the lead. Ultimately, the lead was able to be removed from the header and the device was explanted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[20910553]
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 | 2182208-2012-00037 |
| MDR Report Key | 2448173 |
| Report Source | 00 |
| Date Received | 2012-02-13 |
| Date of Report | 2013-04-03 |
| Date of Event | 2011-10-13 |
| Date Mfgr Received | 2013-04-03 |
| Date Added to Maude | 2012-02-13 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIUMPH VR |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2012-02-13 |
| Model Number | 1124 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE 8200 CORAL SEA ST. N.E. FRIDLEY MN 55112554 US 55112 5543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-02-13 |