MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for TRANSVENOUS LEAD 401658 manufactured by Medtronic, Inc..
[178101847]
Concomitant medical products: a2dr01, implanted on (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178101848]
It was reported that the patient experienced an infection. The implantable pulse generator (ipg), the right atrial (ra) lead and the right ventricular (rv) lead were explanted. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186420170]
Product event summary: the medial portion of the lead was returned, analyzed. Analysis indicated the distal conductor of the lead developed a fracture due to flexing while in vivo. The proximal conductor of the lead developed a fracture due to flexing while in vivo. The inner insulation of the lead developed a breach due to metal ion oxidation while in vivo. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2020-00244 |
| MDR Report Key | 9680446 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-02-07 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| 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 | TRANSVENOUS LEAD |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 401658 |
| Catalog Number | 401658 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 1142 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-07 |