FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3152843
·
Received June 8, 2013
Report
- Report Number
- 2182208-2013-01354
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 11, 2013
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER STYLUS WAS UNABLE TO CALIBRATE. AS A RESULT THE OVERLAY/B EZEL ASSEMBLY WAS REPLACED. IT WAS ALSO NOTED THAT THE STYLUS WAS MISSING.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PRODUCT ID 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD, PRODUCT ID 2290 PACING SYSTEM ANALYZER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER STYLUS WAS CALIBRATED MANY TIMES, BUT IT WAS STILL "WAY OFF" UPON USE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254865 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC, INC. | 2090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |