MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-14 for TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT 5866-38M manufactured by Medtronic, Inc..
[130458343]
Continuation of medical devices: 419478 lead; 419478 lead implanted: (b)(6) 2009; dtbb2d1 icd implanted: (b)(6) 2016. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[130458344]
It was reported that the patient developed an infection caused by the erosion of the cardiac resynchronization therapy defibrillator (crt-d). It was noted that the patient developed a fever. It was also noted that skin necrosis and wound dehiscence was observed. Blood cultures were taken, but the results were not yet obtained. Antibiotics were administered and prescribed for one month. The 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
| Report Number | 2182208-2018-02256 |
| MDR Report Key | 8166366 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2008-02-11 |
| Date Added to Maude | 2018-12-14 |
| 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 | 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 | 2018-12-14 |
| Model Number | 5866-38M |
| Catalog Number | 5866-38M |
| Device Expiration Date | 2010-01-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-12-14 |