MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-24 for TRANSVENOUS 4160 manufactured by Guidant Puerto Rico Bv.
[29172014]
The explanted products were discarded at the hospital. 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
[29172015]
Boston scientific received information that the surgical wound at the device pocket did not close properly and the device was exposed. The system was explanted due to a high risk of infection, and a new system was implanted on the patient铠right side. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2015-11389 |
| MDR Report Key | 5172518 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-24 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-08-06 |
| Date Added to Maude | 2015-10-24 |
| 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 | SONALI VASEKAR |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN |
| Manufacturer Phone | 6515824786 |
| Manufacturer G1 | GUIDANT PUERTO RICO BV |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSVENOUS |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | JSK |
| Date Received | 2015-10-24 |
| Model Number | 4160 |
| ID Number | --- |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUIDANT PUERTO RICO BV |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2015-10-24 |