MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-10-15 for CONCERTO CRT-D DR AT C174AWK manufactured by Medtronic S.a..
[3070846]
It was reported that the device tripped elective replacement indicator and that there may have been premature battery depletion. The device was removed and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10433237]
This event occurred outside the us. All information provided is included in this report. If additional relevant information is received, a supplemental report will be submitted. Patient information is not generally available due to confidentiality concerns. This model number is not approved for distribution in the united states, however, it is same/similar to a device marketed in the u. S. Evaluation summary: (b)(4) - the device met 80% of expected longevity. Without the history of the programmed settings throughout its service life, there is no way to determine why the longevity did not match the predicted model. We did receive performance data collected from the device and have analyzed the data. Battery voltage indicates the device is pre/approaching elective replacement indicator (eri). Weekly battery voltage trend data in save to disk file (b)(4) shows min bat of 2. 86 to 2. 64 volts between (b)(4) 2012 which is before device recommended replacement time (rrt) of less than or equal to 2. 62 volt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000094-2012-02117 |
| MDR Report Key | 2791573 |
| Report Source | 01,05,07 |
| Date Received | 2012-10-15 |
| Date Mfgr Received | 2012-04-26 |
| Device Manufacturer Date | 2008-06-20 |
| Date Added to Maude | 2012-10-16 |
| 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 | RICHARD ROY |
| 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 | 7635262574 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONCERTO CRT-D DR AT |
| Generic Name | IMPLANTABLE PACEMAKER/CARDIO/DEFIB |
| Product Code | LNI |
| Date Received | 2012-10-15 |
| Returned To Mfg | 2012-08-21 |
| Model Number | C174AWK |
| Device Expiration Date | 2009-12-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC S.A. |
| Manufacturer Address | ROUTE DE MOLLIAU 31 TOLOCHENAZ 1131 CH 1131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4196 | 1. Hospitalization; 2. Required No Informationntervention | 2012-10-15 |