MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-08-10 for CARELINK 2490H manufactured by Medtronic Milaca Inc..
[1095016]
The patient reported that the carelink monitor would not turn on. When the patient went to remove the batteries, one battery leaked on the patient's hand causing blisters. The patient declined troubleshooting and stated she will not be using the monitor. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[1283185]
(b) (4)
Patient Sequence No: 1, Text Type: D, B5
[8295236]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Analysis of the device is in process; the results will be forwarded when available.
Patient Sequence No: 1, Text Type: N, H10
[8431452]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Evaluation summary: (b) (4) visual analysis observed corrosion in the battery compartment. The monitor did not power up at initial testing due to the corrosion. During further analysis, the device passed full functional testing. The reported event could not be duplicated. Because batteries are not installed into the battery compartment in the assembly process, the corrosion was suspected to be induced externally.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183613-2009-00014 |
| MDR Report Key | 1434120 |
| Report Source | 04 |
| Date Received | 2009-08-10 |
| Date Mfgr Received | 2009-06-09 |
| Device Manufacturer Date | 2008-12-12 |
| Date Added to Maude | 2010-02-09 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY FREY SR.MDR-VIGILANCE 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 | 7635260577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | ASKU |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARELINK |
| Generic Name | PATIENT MONITORING INSTRUMENT |
| Product Code | DXH |
| Date Received | 2009-08-10 |
| Model Number | 2490H |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MILACA INC. |
| Manufacturer Address | 900 SIXTH AVENUE NE ASKU MILACA MN 56353 US 56353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5076 | 1. Other | 2009-08-10 |