D
Patient 0
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
MAUDE MDR 25341006
- MDR report key
- 25341006
- Report number
- 9614453-2026-02147
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-05-08
- Date received
- 2026-05-31
- Adverse event
- 1
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 1
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- GERARD TORENVLIET
- Address
- 8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
- Phone
- 763-763-7635
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 244088 | COBALT? XT DR MRI SURESCAN? | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | MEDTRONIC EUROPE SARL | LWS | DDPA2D4 | DDPA2D4 | * | N | ||||
| 288051 | COBALT? XT DR MRI SURESCAN? | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | MEDTRONIC EUROPE SARL | LWS | DDPA2D4 | DDPA2D4 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-05-31 | 6935 | H; R |
Event Narratives#
N
Patient 0
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.