REACTIV8
Report
- Report Number
- 3013017877-2024-00051
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Date of Event
- June 12, 2024
- Report Date
- September 7, 2024
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- UDI-DI
- 05391527772064
- PMA / PMN Number
- P190021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MML REFERENCE #: (B)(4). THE DEVICE WAS NOT RETURNED, AND AN ANALYSIS COULD NOT BE PERFORMED BECAUSE THE LEAD WAS DAMAGED DURING THE EXPLANT, AND PARTS WERE LEFT INSIDE THE PATIENT. THEREFORE, THE ALLEGED OUT-OF-RANGE FAILURE CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NONCONFORMANCES WERE FOUND TO BE ASSOCIATED WITH THE OUT-OF-RANGE FAILURE.
MML REFERENCE #: (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE PROGRESSION OF OUT-OF-RANGE/HIGH IMPEDANCE FAILURE OF THE LEFT LEAD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EXPLANT PROCEDURE, THE LEFT LEAD BROKE. THE LEAD FRAGMENTS WERE LEFT INSIDE THE PATIENT AT THE SURGEON'S DISCRETION, AND THE PATIENT CONSENTED. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE PROGRESSION OF OUT-OF-RANGE/HIGH IMPEDANCE FAILURE OF THE LEFT LEAD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EXPLANT PROCEDURE, THE LEFT LEAD BROKE. THE LEAD FRAGMENTS WERE LEFT INSIDE THE PATIENT AT THE SURGEON'S DISCRETION, AND THE PATIENT CONSENTED. A NEW LEAD WAS IMPLANTED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340696 | REACTIV8 | REACTIV8 PERCUTANEOUS STIMULATION LEAD | QLK | MAINSTAY MEDICAL LIMITED | 8145 | 05391527772064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |