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 2018-08-21 for LEAD END CAP KIT 5867-3M manufactured by Mpri.
[117755099]
Concomitant medical products: 5076-58, 457453 lead, implanted: (b)(6) 2007. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117755100]
It was reported that the implantable pulse generator (ipg) system was explanted due to infection of unknown source. Antibiotic treatment was necessary. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2018-13669 |
| MDR Report Key | 7801843 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-07-30 |
| Device Manufacturer Date | 2016-09-22 |
| Date Added to Maude | 2018-08-21 |
| 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 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD END CAP KIT |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2018-08-21 |
| Model Number | 5867-3M |
| Catalog Number | 5867-3M |
| Lot Number | VA1ALZD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 507658 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-21 |