N
Patient 1
WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILLIPS WILL INFORM THE FDA.
MAUDE MDR 7995600
- MDR report key
- 7995600
- Report number
- 3003768277-2018-00080
- Event key
- 0
- Event type
- 3
- Date received
- 2018-10-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. DUSTY LEPPERT
- Address
- VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680 NL
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS CV (CESAR-POWERPACK-VISUB-NICOL) | SYSTEM, X-RAY, ANGIOGRAPHIC | PHILIPS HEALTHCARE | IZI | 722030 | 722030 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-23 | 0 |
Event Narratives#
D
Patient 1
PHILIPS HAS RECEIVED THROUGH (B)(6) A REPORT SUBMITTED BY A CUSTOMER. IN THIS REPORT, THE CUSTOMER REPORTED THAT ?DURING A REVISION OPERATION OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), NO FILMING WITH THE SYSTEM WAS POSSIBLE (FOOT SWITCH DOES NOT WORK AS ON FRIDAY OF THE PREVIOUS WEEK FOR FILMING). THE SAME PROBLEM HAD OCCURRED ON FRIDAY OF THE PREVIOUS WEEK; HOSPITAL MEDICAL TECHNOLOGY WAS INFORMED, WAS ON SITE AND STATED THAT THE PROBLEM HAD BEEN SOLVED. DURING THE PROCEDURE, AFTER 10 MINUTES OF FLUOROSCOPY WITH THE ICD ALREADY EXPOSED, NO FLUOROSCOPY WAS POSSIBLE. A COMPLETE SHUTDOWN OF THE SYSTEM WAS DONE AND THEN AT LEAST FLUOROSCOPY WAS POSSIBLE AGAIN. SIGNIFICANT DELAY OF THE OPERATION TIME (THUS INCREASING RISK OF INFECTION). THE AFFECTED SYSTEM (PHILIPS INTEGRIS CV) DATES FROM 1996 AND IS IN END-OF-SERVICE STATUS. AS A RESULT, THE MANUFACTURER CAN NO LONGER GUARANTEE THE AVAILABILITY OF SPARE PARTS. SO FAR, HOWEVER, ALL MALFUNCTIONS COULD STILL BE REPAIRED. ACCORDING TO THE ORIGINAL REINVESTMENT PLANNING, THE DEVICE WAS TO BE REPLACED THIS YEAR AS PART OF THE PPP CONVERSIONS. DUE TO THE DELAYS IN CONSTRUCTION THAT HAVE OCCURRED IN THE MEANTIME, THE DEVICE IS CURRENTLY STILL IN OPERATION. FROM OUR POINT OF VIEW, THE DEVICE SHOULD NOT AND CAN NO LONGER BE OPERATED?. BECAUSE OF THE ALLEGATION ON POTENTIAL HARM THIS REPORT IS BEING SUBMITTED. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.