FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 2203629
·
Received August 11, 2011
Report
- Report Number
- 2183613-2011-00374
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 10, 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
- 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 CALLER INDICATED THAT THE PATIENT HAS BEEN UNABLE TO TRANSMIT AT THE PHONE PHASE. THE PRODUCT REMAINS IN USE. 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 | 66 YR | Other | (B)(4) IMPLANTABLE PACING LEADS| (B)(4) IMPLANTABLE PULSE GENERATOR |