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 2018-09-17 for TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT 5866-38M manufactured by Medtronic, Inc..
[120516139]
Concomitant medical products: 5568-45 lead, implanted on (b)(6) 2001; 452353s lead, implanted on (b)(6) 1994; 6932-65 lead, implanted on (b)(6) 1996. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120516140]
It was reported that high thresholds, high and undefined impedance and noise were noted on the right atrial (ra) leads. It was noted that a previously implanted adapter was fixed to two ra leads and an implantable cardioverter defibrillator (icd). During the change out of the icd, the leads were capped and replaced with one ra lead and the adapter was removed. When doing the battery change of the icd the physician tested the two ra leads and thresholds were within normal limits. Therefore it was concluded that the adapter may be the issue. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2018-01702 |
| MDR Report Key | 7883536 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-08-25 |
| Date Mfgr Received | 2018-08-25 |
| Device Manufacturer Date | 2012-03-14 |
| Date Added to Maude | 2018-09-17 |
| 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 | 2018-09-17 |
| Model Number | 5866-38M |
| Catalog Number | 5866-38M |
| Device Expiration Date | 2014-02-14 |
| 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 | 2018-09-17 |