MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-06 for INGENIO J172 manufactured by Boston Scientific Corporation.
[174176266]
This event will be further updated upon receipt of additional information.
Patient Sequence No: 1, Text Type: N, H10
[174176267]
It was reported that this device was exhibiting accelerated battery depletion, based on date of implant. To date, no device history nor memory analysis has been assessed to confirm the anomaly. The field representative stated the patient would return for a memory collection so as to have technical service perform an accurate assessment of battery consumption. The device currently remains implanted and in service with no adverse patient effects reported and no further information received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2019-27225 |
| MDR Report Key | 9549714 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-04 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2019-10-29 |
| Device Manufacturer Date | 2014-07-21 |
| 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 | 109273 |
| Device Expiration Date | 2016-07-01 |
| 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 |