MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-14 for 3.2 MM BI LEAD TO IS-1 BI IPG - PERMANENT EXTENSION, ADAPTOR KIT 5866-40M manufactured by Medtronic, Inc..
[120294087]
Concomitant medical products: d224vrc, implanted: (b)(6) 2010; 6966110, implanted: (b)(6) 1994; 6961, implanted: (b)(6) 1994; 6707-15, implanted: (b)(6) 2010; 5866-40m, implanted: (b)(6) 2010. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120294088]
It was reported that during laser lead extraction for a system upgrade, the patient required open heart surgery to repair a small tear in the right ventricle. A new system was implanted a few days later. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2018-01692 |
| MDR Report Key | 7877348 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2009-04-09 |
| Date Added to Maude | 2018-09-14 |
| 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 | 3.2 MM BI LEAD TO IS-1 BI IPG - PERMANENT EXTENSION, ADAPTOR KIT |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2018-09-14 |
| Model Number | 5866-40M |
| Catalog Number | 5866-40M |
| Device Expiration Date | 2011-03-14 |
| 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. Life Threatening; 3. Required No Informationntervention | 2018-09-14 |