MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-02-09 for INGENIO J172 manufactured by Boston Scientific Corporation.
[135678225]
No further information has been provided to date. This report will be updated should additional information become available.
Patient Sequence No: 1, Text Type: N, H10
[135678226]
It was reported that the patient implanted with this device was found with a heart rate of 40 bpm. Upon interrogation, a code 1003 indicative of battery voltage too low for the projected remaining capacity was observed. Device replacement was recommended. This device remains in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2018-64398 |
| MDR Report Key | 8324485 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-09 |
| Date of Report | 2019-02-09 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-17 |
| Device Manufacturer Date | 2015-08-21 |
| Date Added to Maude | 2019-02-09 |
| 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 | 2019-02-09 |
| Model Number | J172 |
| Catalog Number | J172 |
| Lot Number | 295471 |
| Device Expiration Date | 2017-08-21 |
| 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 | 2019-02-09 |