FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1928977
·
Received November 16, 2010
Report
- Report Number
- 9614453-2010-09617
- Event Type
- Malfunction
- Date Received
- November 16, 2010
- Date of Event
- November 9, 2010
- Report Date
- November 9, 2010
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF SYMPTOMS (MOTOR AND VOCAL TICS). X-RAYS SHOWED THAT THE CONDUCTORS OF THE RIGHT LEAD COULD BE BROKEN. IMPEDANCE TESTS REPORTED IMPEDANCES >4000 ON THE SECOND CHANNEL EVEN AT 6 V OF AMPLITUDE. THE PROGRAMMING PARAMETERS ARE 0-CASE+ AND 4-CASE+ AT 2.8 V, 120 MICROSEC, 130 HZ. A REVISION SURGERY WAS GOING TO BE PERFORMED, BUT THE DATE WAS NOT YET SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC EUROPE SARL | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| LEAD: MODEL 3389, LOT# UNK| IMPLANTED: |