FDA Adverse Event
Malfunction
Summary report: N
CARELINK
MDR report key: 3050950
·
Received April 10, 2013
Report
- Report Number
- 2182208-2013-01042
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Report Date
- February 27, 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
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE FAILED TELEMETRY TESTING DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS RETURNED BECAUSE IT WAS THE WRONG ITEM. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149767 | CARELINK | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | RICE CREEK MFG | 2067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |