FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2131919
·
Received June 16, 2011
Report
- Report Number
- 2183613-2011-00215
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 29, 2011
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S79
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 CARELINK MONITOR WOULD NOT TRANSMIT THE PATIENT'S PACEMAKER INTERROGATION FROM THE NURSING HOME FACILITY AFTER THE TELEPHONE LINE HAD BEEN CHANGED. MULTIPLE CONFIGURATIONS WERE ATTEMPTED WITH THE EXTERNAL DIAL NUMBERS ON THE CARELINK MONITOR. NEW CARELINK MONITOR TO BE ORDERED AND SENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK | PATIENT MONITORING INSTRUMENT | DXY | MEDTRONIC MILACA INC. | 2490H | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other | 4092 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |