MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2011-08-11 for CARELINK 2490C8 manufactured by Plexus Manufacturing Sdn. Bhd..
[2192284]
It was reported by the patient that the remote monitor was not receiving power. A new power cord did not resolve the issue. It was also reported that when the monitor was plugged the home's phones were not working. The monitor was replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9144864]
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
[27677174]
.
Patient Sequence No: 1, Text Type: N, H10
[27677175]
It was further reported that the monitor has been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2011-00102 |
| MDR Report Key | 2207568 |
| Report Source | 04,CONSUMER |
| Date Received | 2011-08-11 |
| Date Mfgr Received | 2015-07-24 |
| Device Manufacturer Date | 2011-03-30 |
| Date Added to Maude | 2012-06-21 |
| 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 8200 CORAL SEA ST. N.E. |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | ASKU |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARELINK |
| Generic Name | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
| Product Code | DXH |
| Date Received | 2011-08-11 |
| Returned To Mfg | 2015-07-24 |
| Model Number | 2490C8 |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD. |
| Manufacturer Address | BAYAN LEPAS FREE INDUST. ZONE 11900 BAYAN LEPAS PENANG ASKU MY ASKU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 6947 | 1. Other | 2011-08-11 |