FDA Adverse Event
Malfunction
Summary report: N
PULSE GENERATOR, PERMANENT, IMPLANTABLE
MDR report key: 17527382
·
Received August 12, 2023
Report
- Report Number
- MW5134314
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- July 29, 2014
- Manufacturer
- SORIN
- Product Code
- NVZ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE LEAD WAS NOTED ON (B)(6) 2014 DUE TO VARIATIONS OF IMPEDANCE SIMULATION >2500 OHMS, THE THRESHOLD IMPEDANCE IS >7V AND THE R WAVE INTRINSIC IMPEDANCE IS AROUND 3MV. THE PHYSICIAN DECIDED TO CHANGE THE STIMULATOR. DURING THE REPLACEMENT, NO UNSCREWING ISSUES AND THE MEASUREMENTS OF THE LEAD PARAMETERS ARE COMPLETELY CORRECT: IMPEDANCE: 510 OHMS, STIMULATION THRESHOLD: AROUND 1 V AND WAVE INTRINSIC IMPEDANCE R= 8 TO 1 O MV) THE PHYSICIAN DECIDED TO KEEP THE LEAD AND CONNECTED IT TO A NEW PACEMAKER OF SORIN BRAND AND EVERYTHING WORKED WELL. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) IN FRANCE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597423 | PULSE GENERATOR, PERMANENT, IMPLANTABLE | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN | X FINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |