MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-10 for ENDOTAK RELIANCE 0692 manufactured by Cpi - Del Caribe.
[89109766]
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
[89109769]
Boston scientific received information that one week post-implant this right ventricular (rv) lead exhibited increased/high pacing thresholds. A chest x-ray was performed showing the lead to be tensioned without slack. A revision procedure was performed the following day wherein the lead was successfully repositioned with additional slack. No adverse patient effects were reported. This lead remains in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2017-16968 |
| MDR Report Key | 6934622 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2016-11-02 |
| Date Added to Maude | 2017-10-10 |
| 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 | TIM DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | CPI - DEL CARIBE |
| Manufacturer Street | GUIDANT PUERTO RICO B. V. |
| Manufacturer City | DORADO PR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTAK RELIANCE |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | DXG |
| Date Received | 2017-10-10 |
| Model Number | 0692 |
| ID Number | RELIANCE 4-FRONT |
| Device Expiration Date | 2018-11-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CPI - DEL CARIBE |
| Manufacturer Address | GUIDANT PUERTO RICO B. V. DORADO PR |
| Brand Name | ENDOTAK RELIANCE |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | DBT |
| Date Received | 2017-10-10 |
| Model Number | 0692 |
| ID Number | RELIANCE 4-FRONT |
| Device Expiration Date | 2018-11-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CPI - DEL CARIBE |
| Manufacturer Address | GUIDANT PUERTO RICO B. V. DORADO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-10-10 |