MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-17 for ICS 3000 OM-3 US 349530 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[3656939]
Ous mdr - on (b)(6) 2013, the new implantation of a cardiac pacemaker was planned. The (b)(6) female patient had an indication of a 3rd degree av block and recurring syncope's. During implantation, complications arose, which necessitated intubation and calling for an emergency team. During the resuscitation attempts, a lead was placed for the purpose of stimulation. Since the available external defibrillator had no pacing function and since no other external stimulator was available, pacing was temporarily performed with this programmer via the implant module. This stimulation was successful. Nevertheless, the patient remained in an unstable state with vf episodes and the necessity of repeated external defibrillation. A second lead was implanted, which was connected to this programmer. Still the state of the patient remained critical, accompanied by tachycardia and a drop in blood pressure. Due to a medical will by the patient, she was not connected to a ventilator. The patient died. It was reported that towards the end of the operation, a brief pacing loss of the programmer was observed after the device had been moved around on the table. This observation during the emergency measures was however, not seen as the cause for the clinical event.
Patient Sequence No: 1, Text Type: D, B5
[15600440]
The programmer underwent a functional and a visual/mechanical check. The following describes the results of the functional check. The device underwent a functional check. It was divided into the following analysis steps: startup of the device, check of the user program and its operation, check of the display elements, interfaces, and the periphery (monitor, printer, programming wand). Test of pacing and sensing. The device was activated, and the operating system and the user program were started. The device could be operated without restrictions via the touch-sensitive screen. Implants could be interrogated successfully and reliably. Data could be transmitted from the implant to the programmer and vice versa without errors. When the programming wand was electrically separated from the control unit, an error message appeared as expected. The functioning of pacing and sensing was checked with the help of a heart simulator. The device detected as expected and paced. There were no pacing losses, not even during the long-term test. The device then underwent a mechanical provocation test. When applying strong external mechanical stress on individual device parts, a brief intermittent contact interruption between control and pacing unit could be observed. During the analysis, a deformation of the housing, which was probably caused by external mechanical stress, was noted. In addition, a noticeable amount of dirt was found in the contacting area. After cleaning the contacting area, final factory testing was performed, which was passed by the device. The review of the production documents regarding the programmer did not show any anomalies. In summary, there was no indication of a material defect or manufacturing error. Both the dirt at the contacts and the housing deformation could have possibly contributed to the behavior of the device observed after the operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2013-01983 |
| MDR Report Key | 3232146 |
| Report Source | 01,07 |
| Date Received | 2013-07-17 |
| Date of Report | 2013-07-04 |
| Date of Event | 2013-06-13 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2009-12-14 |
| Date Added to Maude | 2013-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICS 3000 OM-3 US |
| Generic Name | PROGRAMMER |
| Product Code | OVJ |
| Date Received | 2013-07-17 |
| Model Number | 349530 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-07-17 |