MICRA
Report
- Report Number
- 9612164-2024-05258
- Event Type
- Malfunction
- Date Received
- November 13, 2024
- Date of Event
- November 5, 2024
- Report Date
- November 26, 2024
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- PNJ
- PMA / PMN Number
- P150033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT EVENT SUMMARY: A PARTIAL DELIVERY SYSTEM WAS RETURNED AND ANALYZED. THE DELIVERY SYSTEM OUTER SHAFT WAS KINKED/BUCKLED. THE DELIVERY SYSTEM INNER SHAFT WAS MECHANICALLY KINKED/BENT. VISUAL ANALYSIS OF THE DELIVERY SYSTEM INDICATED DAMAGE DURING USE. THE ANALYST NOTED A PARTIAL DELIVERY SYSTEM WAS RETURNED WITHOUT THE DEVICE, TETHER, AND TETHER PIN. THE OUTER SHAFT WAS KINK/BUCKLED AT 6 CM FROM THE DISTAL END OF THE DELIVERY SYSTEM. THE INNER SHAFT IS KINKED AT 3.5 CM FROM THE DISTAL END OF THE RECAPTURE CONE. THERE WERE NO ANOMALIES FOUND DURING ARTICULATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THAT THE DELIVERY FORCE WAS NOT TRANSMITTED TO THE TIP OF THE DELIVERY SYSTEM (DS). IT WAS ALSO REPORTED THAT THE STRENGTH OF THE DS WAS LESS THAN OTHER IMPLANTS. IT WAS FURTHER REPORTED THAT THE PHYSICIAN FELT THAT THE DS HAD LESS RESISTANCE THAN OTHER IMPLANTS. THE LEADLESS IPG WAS SUCCESSFULLY IMPLANTED AND REMAINS IN USE AND THE DS WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THAT THE DELIVERY FORCE WAS NOT TRANSMITTED TO THE TIP OF THE DELIVERY SYSTEM (DS). IT WAS ALSO REPORTED THAT THE STRENGTH OF THE DS WAS LESS THAN OTHER IMPLANTS. IT WAS FURTHER REPORTED THAT THE PHYSICIAN FELT THAT THE DS HAD LESS RESISTANCE THAN OTHER IMPLANTS THE LEADLESS IPG WAS SUCCESSFULLY IMPLANTED AND WAS LATER REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THAT THE DELIVERY FORCE WAS NOT TRANSMITTED TO THE TIP OF THE DELIVERY SYSTEM (DS). IT WAS ALSO REPORTED THAT THE STRENGTH OF THE DS WAS LESS THAN OTHER IMPLANTS. IT WAS FURTHER REPORTED THAT THE PHYSICIAN FELT THAT THE DS HAD LESS RESISTANCE THAN OTHER IMPLANTS THE LEADLESS IPG WAS SUCCESSFULLY IMPLANTED AND 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 |
|---|---|---|---|---|---|---|---|
| 2069293 | MICRA | LEADLESS PACEMAKER | PNJ | MEDTRONIC IRELAND | MC1VR01-DELSYS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |