MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-09-24 for MEDTRONIC CARELINK MONITOR MEDT/CLM manufactured by Medtronic Milaca Inc..
[1426355]
It was reported the patient had 3 vf (ventricular fibrillation) episodes, but only one "was actually transmitted to the carelink website. " the patient was found dead 2 days later in his bed. There is no allegation from a health care professional that the death was device related. The cause of death has been requested and not received.
Patient Sequence No: 1, Text Type: D, B5
[8763885]
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. Without a lot number or device serial number, the manufacturing date cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183613-2010-00152 |
| MDR Report Key | 1843408 |
| Report Source | 01,05 |
| Date Received | 2010-09-24 |
| Date of Event | 2010-08-25 |
| Date Mfgr Received | 2010-09-07 |
| Date Added to Maude | 2010-09-24 |
| 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 | ANNETTE MULCAHY VIGILANCE OPERATIONS DIR |
| 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 | 7635263516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | ASKU |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC CARELINK MONITOR |
| Generic Name | PATIENT MONITORING INSTRUMENT |
| Product Code | DXH |
| Date Received | 2010-09-24 |
| Model Number | MEDT/CLM |
| 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 MILACA INC. |
| Manufacturer Address | 900 SIXTH AVENUE NE ASKU MILACA MN 56353 US 56353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-09-24 |