MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-12 for TELIGEN F102 manufactured by Guidant Crm Clonmel Ireland.
[64653234]
An investigation into this issue is currently ongoing. Once any additional information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[64653235]
Boston scientific received information that the patient with this device went to the hospital after experiencing a loss of consciousness. Interrogation of the device revealed that there were no episodes stored and the electrical parameters were in an acceptable range and stable. It was noted that the device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity. No additional adverse patient effects were reported. The patient was hospitalized for further testing in the nephrology department. Once testing is completed, the device will be scheduled for explant. Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to a product performance anomaly. Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion. This particular device was included in the advisory population.
Patient Sequence No: 1, Text Type: D, B5
[65922620]
Patient Sequence No: 1, Text Type: N, H10
[65922621]
Patient Sequence No: 1, Text Type: D, B5
[74270374]
It is unknown when this device will be explanted as the patient is refusing to undergo an explant procedure. At this time, it remains implanted and in service. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
[74270375]
Additional information was received that the patient is refusing to have the device explanted. Another memory download was sent to boston scientific technical services (ts) to evaluate the current depletion of the device. A ts consultant discussed that the power consumption continues to remain stable; however, device explant within 28 days was still recommended. No adverse patient effects were reported. This information was to be provided to the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2016-21611 |
| MDR Report Key | 6246218 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-12 |
| Date of Report | 2017-03-06 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2017-03-06 |
| Device Manufacturer Date | 2009-09-15 |
| Date Added to Maude | 2017-01-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONALI VASEKAR |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN |
| Manufacturer Phone | 6515824786 |
| Manufacturer G1 | GUIDANT CRM CLONMEL IRELAND |
| Manufacturer Street | GUIDANT IRELAND |
| Manufacturer City | CLONMEL, TIPPERARY IRELAND |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0026-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELIGEN |
| Generic Name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | LWW |
| Date Received | 2017-01-12 |
| Model Number | F102 |
| ID Number | TELIGEN |
| Device Expiration Date | 2010-09-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUIDANT CRM CLONMEL IRELAND |
| Manufacturer Address | GUIDANT IRELAND CLONMEL, TIPPERARY IRELAND |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2017-01-12 |