MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-22 for INGENIO J172 manufactured by Boston Scientific Corporation.
[142681913]
Following completion of analysis, a follow-up report will be completed.
Patient Sequence No: 1, Text Type: N, H10
[142681914]
It was reported that during the attempted implant of this device, upon lead insertion, the pacing frequency was lower than the marked frequency. For this reason, the device was removed and returned for analysis. No resulting adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2019-07210 |
| MDR Report Key | 8537569 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-22 |
| Date of Report | 2019-06-21 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-06-03 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2019-04-22 |
| 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 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 | 2019-04-22 |
| Returned To Mfg | 2019-04-02 |
| Model Number | J172 |
| Catalog Number | J172 |
| Lot Number | 296495 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-04-22 |