MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-03 for UNIPOLAR LEAD BODY TO IS-1 IPG LEAD ADAPTOR KIT 58669M manufactured by Medtronic, Inc..
[140739613]
Product event summary: the proximal portion of the lead was returned and analyzed. The analysis indicated that the distal conductor of the lead developed a fracture due to flexing while in vivo. The outer insulation of the lead developed a breach due to a depression while in vivo. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[140739614]
The lead was returned, analyzed and tested out of specification. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2019-00634 |
| MDR Report Key | 8477063 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-04-03 |
| 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 | LISA ROBERTSON |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635262723 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIPOLAR LEAD BODY TO IS-1 IPG LEAD ADAPTOR KIT |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-02-26 |
| Model Number | 58669M |
| Catalog Number | 58669M |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |