FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3160289
·
Received June 10, 2013
Report
- Report Number
- 2182208-2013-01813
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- RICE CREEK MFG
- 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT THE PROGRAMMER WOULD NOT INTERROGATE A DEVICE. THE SR PLACED PRESSURE ON THE RADIO-FREQUENCY (RF) HEAD CONNECTOR AND WAS THEN ABLE TO COMPLETE THE INTERROGATION. THE SR STATED THAT THE RF HEAD CONNECTION WAS BAD, AND THE PROGRAMMER WOULD BE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259688 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2090AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD |