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 2020-03-17 for IMPLANTABLE PACEMAKER PULSE-GENERATOR manufactured by Boston Scientific Corporation.
[183752307]
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183752308]
It was reported that, during a normal device changeout procedure, the insulation on the existing right ventricular (rv) lead was damaged. Subsequently, this rv lead was capped/surgically abandoned, and another lead was successfully placed. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-05368 |
| MDR Report Key | 9842709 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2019-08-21 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANTABLE PACEMAKER PULSE-GENERATOR |
| Product Code | DXY |
| Date Received | 2020-03-17 |
| 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 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-17 |