MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-19 for LEAD ADAPTOR 511214 manufactured by Greatbatch Medical.
[124363032]
As reported: the epicardial lead with the adapter was not functioning and the physician opted to place a transvenous lead. No additional information was provided. This is a similar event as mdr 2183787-2018-00083.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183787-2018-00084 |
| MDR Report Key | 7985172 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-19 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2018-10-19 |
| 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 | RHONDA STAGER |
| Manufacturer Street | 2300 BERKSHIRE LANE |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7639518376 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD ADAPTOR |
| Generic Name | BIPOLAR LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2018-10-19 |
| Model Number | 511214 |
| Lot Number | W4113507 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREATBATCH MEDICAL |
| Manufacturer Address | 2300 BERKSHIRE LANE MINNEAPOLIS MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |