TEO
Report
- Report Number
- 1000165971-2024-01062
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- October 14, 2024
- Report Date
- December 18, 2024
- Manufacturer
- MICROPORT CRM S.R.L.
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. THE UDI IS MISSING, WE ARE LOOKING FOR IT AND IT WILL BE SHARED IN THE NEXT FOLLOW-UP MDR. THE ELECTRICAL CHARACTERISTICS OF THE RETURNED DEVICE CONFORMED TO ESTABLISHED SPECIFICATIONS. UPON RECEPTION OF THE DEVICE, PACING PULSES WERE GENERATED APPROPRIATELY BY THE DEVICE. THE VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITY. THE ANALYSIS CONFIRMS THAT THE CONNECTION SYSTEM OF THE SUBJECT PACEMAKER FUNCTIONED AS SPECIFIED USING A DUPLICATE TORQUE-LIMITING SCREWDRIVER. SEVERAL OBSERVATIONS WERE NOTICED DURING THE DEVICE¿S INVESTIGATION: THE SILICON SLITS OVER THE ATRIAL SETSCREW CAVITY AND OVER THE VENTRICULAR SETSCREW CAVITY WERE FOUND DAMAGED. CORRECT, AS WELL AS INCORRECT TIGHTENING MARKS WERE NOTED ON THE ATRIAL AND THE VENTRICULAR SETSCREW TIPS. A LIKELY HYPOTHESIS IS THAT THE PHYSICIAN HAD PARTIALLY ENGAGED THE SETSCREW AT SOME POINTS BEFORE INSERTING THE LEAD OR THAT HE HAD NOT INSERTED THE LEAD ALL THE WAY IN BEFORE TIGHTENING THE SETSCREW INDUCING AN INTERMITTENT. THIS HYPOTHESIS COULD EXPLAIN THE ISSUE REPORTED IN THE COMPLAINT (ABSENCE OF PACING AND OVERSENSING LIKE 50HZ). BASED ON THE AVAILABLE DATA, NO ISSUE IS SUSPECTED ON THE SUBJECT PACEMAKER. THE COMPLAINT IS RECORDED FOR TRENDING PURPOSES. DISPOSE D¿UN MENU CONTEXTUEL
THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. THE UDI IS MISSING, WE ARE LOOKING FOR IT AND IT WILL BE SHARED IN THE NEXT FOLLOW-UP MDR. THANKS FOR YOUR UNDERSTANDING.
THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. THE UDI HAS BEEN INCLUDED IN THIS MDR FOLLOW-UP. THE ELECTRICAL CHARACTERISTICS OF THE RETURNED DEVICE CONFORMED TO ESTABLISHED SPECIFICATIONS. UPON RECEPTION OF THE DEVICE, PACING PULSES WERE GENERATED APPROPRIATELY BY THE DEVICE. THE VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITY. THE ANALYSIS CONFIRMS THAT THE CONNECTION SYSTEM OF THE SUBJECT PACEMAKER FUNCTIONED AS SPECIFIED USING A DUPLICATE TORQUE-LIMITING SCREWDRIVER. SEVERAL OBSERVATIONS WERE NOTICED DURING THE DEVICE¿S INVESTIGATION: THE SILICON SLITS OVER THE ATRIAL SETSCREW CAVITY AND OVER THE VENTRICULAR SETSCREW CAVITY WERE FOUND DAMAGED. CORRECT, AS WELL AS INCORRECT TIGHTENING MARKS WERE NOTED ON THE ATRIAL AND THE VENTRICULAR SETSCREW TIPS. A LIKELY HYPOTHESIS IS THAT THE PHYSICIAN HAD PARTIALLY ENGAGED THE SETSCREW AT SOME POINTS BEFORE INSERTING THE LEAD OR THAT HE HAD NOT INSERTED THE LEAD ALL THE WAY IN BEFORE TIGHTENING THE SETSCREW INDUCING AN INTERMITTENT. THIS HYPOTHESIS COULD EXPLAIN THE ISSUE REPORTED IN THE COMPLAINT (ABSENCE OF PACING AND OVERSENSING LIKE 50HZ). BASED ON THE AVAILABLE DATA, NO ISSUE IS SUSPECTED ON THE SUBJECT PACEMAKER. THE COMPLAINT IS RECORDED FOR TRENDING PURPOSES. DISPOSE D¿UN MENU CONTEXTUEL.
REPORTEDLY, DURING THE IMPLANTATION OF THE DEVICE IN A NON-PACEMAKER DEPENDENT PATIENT, THE INVOLVED PACEMAKER FAILED TO PACE AFTER CONNECTION OF THE LEADS. PSA MEASUREMENTS WERE NORMAL. THE DEVICE WAS CONNECTED SEVERALL TIMES AFTER CLEANING THE CONNECTORS BUT STILL NO PACING WAS SEEN. VERY HIGH VENTRICULAR RATE OF SENSED EVENTS WAS OBSERVED (KIND OF LIKE 50 HZ). A NEW PACEMAKER WAS CONNECTED AND NO PROBLEMS WERE OBSERVED ANYMORE.
REPORTEDLY, DURING THE IMPLANTATION OF THE DEVICE IN A NON-PACEMAKER DEPENDENT PATIENT, THE INVOLVED PACEMAKER FAILED TO PACE AFTER CONNECTION OF THE LEADS. PSA MEASUREMENTS WERE NORMAL. THE DEVICE WAS CONNECTED SEVERALL TIMES AFTER CLEANING THE CONNECTORS BUT STILL NO PACING WAS SEEN. VERY HIGH VENTRICULAR RATE OF SENSED EVENTS WAS OBSERVED (KIND OF LIKE 50 HZ). A NEW PACEMAKER WAS CONNECTED AND NO PROBLEMS WERE OBSERVED ANYMORE.
REPORTEDLY, DURING THE IMPLANTATION OF THE DEVICE IN A NON-PACEMAKER DEPENDENT PATIENT, THE INVOLVED PACEMAKER FAILED TO PACE AFTER CONNECTION OF THE LEADS. PSA MEASUREMENTS WERE NORMAL. THE DEVICE WAS CONNECTED SEVERALL TIMES AFTER CLEANING THE CONNECTORS BUT STILL NO PACING WAS SEEN. VERY HIGH VENTRICULAR RATE OF SENSED EVENTS WAS OBSERVED (KIND OF LIKE 50 HZ). A NEW PACEMAKER WAS CONNECTED AND NO PROBLEMS WERE OBSERVED ANYMORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1644468 | TEO | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | MICROPORT CRM S.R.L. | TEO DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |