MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-25 for INGENIO J172 manufactured by Boston Scientific Corporation.
[125033244]
An investigation into this event is currently ongoing.
Patient Sequence No: 1, Text Type: N, H10
[125033245]
It was reported that this pacemaker oversensed noise resulting in pacing inhibition with asystole for more than two seconds. The patient is pacemaker dependent patient and was syncopal. The patient was prescribed a holter monitor which confirmed frequent instances of noise with pacing inhibition. Isometrics and pocket manipulation were successfully in recreating noise. The device was reprogrammed and intervention is likely.
Patient Sequence No: 1, Text Type: D, B5
[131952437]
The product has been received for analysis. This report will be updated upon completion of analysis.
Patient Sequence No: 1, Text Type: N, H10
[131952438]
It was reported that this pacemaker oversensed noise resulting in pacing inhibition with asystole for more than two seconds. The patient is pacemaker dependent patient and was syncopal. The patient was prescribed a holter monitor which confirmed frequent instances of noise with pacing inhibition. Isometrics and pocket manipulation were successfully in recreating noise. The device was reprogrammed and intervention is likely. The device was explanted.
Patient Sequence No: 1, Text Type: D, B5
[140202582]
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed. A visual inspection of the device header and case noted no anomalies. Pin gauge testing, designed to verify proper port dimensions, was completed. Each port measured as expected. The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested. Impedance testing was completed and all measurements were within normal limits. The device operated appropriately with no interruptions in therapy output at the returned programmed settings. A series of electrical tests was also performed, and again, normal device function was observed.
Patient Sequence No: 1, Text Type: N, H10
[140202584]
It was reported that this pacemaker oversensed noise resulting in pacing inhibition with asystole for more than two seconds. The patient is pacemaker dependent patient and was syncopal. The patient was prescribed a holter monitor which confirmed frequent instances of noise with pacing inhibition. Isometrics and pocket manipulation were successfully in recreating noise. The device was reprogrammed and intervention is likely. The device was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2018-60066 |
| MDR Report Key | 8006187 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-25 |
| Date of Report | 2019-01-03 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2013-01-30 |
| Date Added to Maude | 2018-10-25 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH , |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CLONMEL LIMITED |
| Manufacturer Street | CASHEL ROAD , |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INGENIO |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
| Product Code | LWW |
| Date Received | 2018-10-25 |
| Returned To Mfg | 2018-11-12 |
| Model Number | J172 |
| Catalog Number | J172 |
| Lot Number | 104137 |
| Device Expiration Date | 2015-01-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH , SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-10-25 |