MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-25 for TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT 5866-38M manufactured by Medtronic, Inc..
[137059036]
Concomitant medical products: c2tr01 ipg; 383069 lead; 419478 lead, implanted: (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137059037]
It was reported that the patient developed a pocket infection and lead erosion. Antibiotics were administered and the cardiac resynchronization therapy defibrillator (crt-d) system was removed. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[140200213]
Evaluation summary: the full lead was returned and analyzed, and no anomalies were found. Visual analysis of the lead indicated apparent explant damage. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2019-00345 |
| MDR Report Key | 8367599 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-25 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2009-01-13 |
| Date Added to Maude | 2019-02-25 |
| 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 | TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2019-02-25 |
| Returned To Mfg | 2019-02-13 |
| Model Number | 5866-38M |
| Catalog Number | 5866-38M |
| Device Expiration Date | 2010-12-28 |
| 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 | 5071 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-25 |