FDA Adverse Event
Malfunction
Summary report: N
THERA DR
MDR report key: 3863427
·
Received June 10, 2014
Report
- Report Number
- 2647346-2014-00050
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 5, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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. CONCOMITANT PRODUCT: 4024-58 LEAD, IMPLANTED: (B)(6) 1995. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE CANNOT BE INTERROGATED. THERE WAS NO PACER SPIKES SEEN ON ELECTROCARDIOGRAM (ECG) AND NO MAGNET RESPONSE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341041 | THERA DR | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC PUERTO RICO | 7940B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | 4524-53 LEAD |