MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for 5 MM BIFURCATED BIPOLAR LEAD OR TWO 5 MM UNI LEADS TO IS-1 BIPOLAR IPG ADAPTOR 5866-24M manufactured by Rice Creek Mfg.
[123972000]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123972001]
It was reported that the pacing lead was exhibiting noise. The lead remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-2018-00085 |
| MDR Report Key | 7970093 |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2010-01-05 |
| Date Added to Maude | 2018-10-16 |
| 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 | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | RICE CREEK MFG |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | FRIDLEY MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 5 MM BIFURCATED BIPOLAR LEAD OR TWO 5 MM UNI LEADS TO IS-1 BIPOLAR IPG ADAPTOR |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2018-10-16 |
| Model Number | 5866-24M |
| Catalog Number | 5866-24M |
| Device Expiration Date | 2011-12-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |