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 2020-01-06 for INGENIO J172 manufactured by Boston Scientific Corporation.
[174668619]
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
[174668620]
It was reported during a routine follow up appointment this pacemaker device and competitors rv lead, had noise, oversensing on the rv channel, which lead to pacing inhibition. There was an unknown duration of asystole. The device was reprogrammed and remains implanted. No adverse patient effects were reported. Technical service consultant discussed having the patient return to clinic for additional evaluation of the rv lead. At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2019-26142 |
| MDR Report Key | 9550086 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-04 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2019-11-13 |
| Device Manufacturer Date | 2013-06-27 |
| Date Added to Maude | 2020-01-06 |
| 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 CORPORATION |
| 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 | 2020-01-06 |
| Model Number | J172 |
| Catalog Number | J172 |
| Lot Number | 105922 |
| Device Expiration Date | 2015-06-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-06 |