FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3151502
·
Received June 7, 2013
Report
- Report Number
- 2182208-2013-01156
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CABLE IS FRAYED. ANALYSIS ALSO FOUND THE LABEL COATING IS 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. PRODUCT ID 2090 PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORD ON THE RADIO FREQUENCY PROGRAMMER HEAD WAS FRAYED. THE HEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 253369 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MANUFACTURING | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |