FDA Adverse Event
Malfunction
Summary report: N
THERA-I DR
MDR report key: 3993401
·
Received August 8, 2014
Report
- Report Number
- 2647346-2014-00067
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 9, 2014
- Report Date
- June 9, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
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 THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED. NO PACING WAS OBSERVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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 |
|---|---|---|---|---|---|---|---|
| 471761 | THERA-I DR | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MDT PUERTO RICO OPERATIONS CO, MED REL | 7960IB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | 4524-53, 503458 LEADS |