PLATINIUM
Report
- Report Number
- 1000165971-2025-00052
- Event Type
- Malfunction
- Date Received
- January 20, 2025
- Date of Event
- December 1, 2024
- Report Date
- July 11, 2025
- Manufacturer
- MICROPORT CRM S.R.L.
- Product Code
- LWS
- UDI-DI
- 08031527015361
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
PLEASE FIND ATTACHED THE REPORT PRELIMINARY ANALYSIS OF THE AVAILABLE PATIENT FILES REVEALED: O AN ABNORMAL BATTERY DEPLETION O NO OVERCONSUMPTION. THE EXPERTISE OF THE RETURNED ICD DIDN¿T REVEAL OVER-CONSUMPTION. THE BATTERY ANALYSIS REVEALED 2 CLUSTERS WERE FOUND INSIDE THE BATTERY. ONE OF THESE CLUSTERS WAS IN CLOSE PROXIMITY TO THE CATHODE BRIDGE, AND LEAD TO THE FAST BATTERY DEPLETION. THE BATTERY FAILURE IS THE ROOT CAUSE OF THE FAST BATTERY DEPLETION.
PLEASE FIND ATTACHED THE INTERMEDIATE REPORT PRELIMINARY ANALYSIS OF THE AVAILABLE PATIENT FILES REVEALED: O AN ABNORMAL BATTERY DEPLETION O NO OVERCONSUMPTION - THE EXPERTISE OF THE RETURNED ICD DIDN¿T REVEAL OVER-CONSUMPTION. - THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. THE MOST LIKELY HYPOTHESIS WOULD BE A BATTERY FAILURE. FURTHER INVESTIGATIONS ARE ONGOING AT THE BATTERY MANUFACTURER LEVEL.
PLEASE REFER TO THE ATTACHED REPORT PRELIMINARY ANALYSIS OF THE AVAILABLE PATIENT FILES REVEALED: O AN ABNORMAL BATTERY DEPLETION O NO OVERCONSUMPTION BASED ON AVAILABLE INFORMATION, A BATTERY ISSUE IS SUSPECTED. IN THIS CASE, THE BATTERY VOLTAGE COULD DECREASE AGAIN VERY RAPIDLY, THEREFORE THE RRT COULD BE REACHED VERY RAPIDLY. A DEVICE EXPLANTATION SHOULD BE CONSIDERED AS SOON AS POSSIBLE.
REPORTEDLY, THE BATTERY LONGEVITY WAS 7 YEARS AND THE BATTERY VOLTAGE WAS 2.97V AT THE LAST FOLLOW UP 6 MONTHS AGO, BUT THEY WERE SUDDENLY DECREASED 1 YEAR AND 2.74V AT THE LATEST FOLLOW UP ON 24-DEC-2024. NEXT FOLLOW UP IS PLANNED IN 3 MONTH.
REPORTEDLY, THE BATTERY LONGEVITY WAS 7 YEARS AND THE BATTERY VOLTAGE WAS 2.97V AT THE LAST FOLLOW UP 6 MONTHS AGO, BUT THEY WERE SUDDENLY DECREASED 1 YEAR AND 2.74V AT THE LATEST FOLLOW UP ON 24-DEC-2024. NEXT FOLLOW UP IS PLANNED IN 3 MONTH.
REPORTEDLY, THE BATTERY LONGEVITY WAS 7 YEARS AND THE BATTERY VOLTAGE WAS 2.97V AT THE LAST FOLLOW UP 6 MONTHS AGO, BUT THEY WERE SUDDENLY DECREASED 1 YEAR AND 2.74V AT THE LATEST FOLLOW UP ON (B)(6) 2024. NEXT FOLLOW UP IS PLANNED IN 3 MONTH.
REPORTEDLY, THE BATTERY LONGEVITY WAS 7 YEARS AND THE BATTERY VOLTAGE WAS 2.97V AT THE LAST FOLLOW UP 6 MONTHS AGO, BUT THEY WERE SUDDENLY DECREASED 1 YEAR AND 2.74V AT THE LATEST FOLLOW UP ON 24-DEC-2024. NEXT FOLLOW UP IS PLANNED IN 3 MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440560 | PLATINIUM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MICROPORT CRM S.R.L. | PLATINIUM VR 1210 | 08031527015361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |