FDA Adverse Event
Malfunction
Summary report: N
CARELINK SYSTEM
MDR report key: 2448980
·
Received February 13, 2012
Report
- Report Number
- 2182208-2012-00069
- Event Type
- Malfunction
- Date Received
- February 13, 2012
- Date of Event
- November 9, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- OUG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CLINIC WAS NOT NOTIFIED OF A RED ALERT FOR A PATIENT. THE NOTIFICATION METHOD WAS TESTED AND NOT RECEIVED. IT WAS DETERMINED THAT THE PATIENT DOES NOT LEAVE THE REMOTE MONITOR CONNECTED AT ALL TIMES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK SYSTEM | SOFTWARE | OUG | MEDTRONIC, INC. | CARELINK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD |