MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-08 for MINIX 8340 manufactured by Mdt Puerto Rico Operations Co, Med Rel.
[3488065]
It was reported that the patient came to the clinic programmed differently. The patient was previously programmed at vvi 70 and is now programmed vvi 40. The device remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10839353]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647346-2013-00072 |
| MDR Report Key | 3157602 |
| Report Source | 05 |
| Date Received | 2013-06-08 |
| Date of Report | 2013-04-05 |
| Date Mfgr Received | 2013-04-05 |
| Date Added to Maude | 2013-09-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| Manufacturer Street | 8200 CORAL SEA ST 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 | MINIX |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2013-06-08 |
| Model Number | 8340 |
| Catalog Number | 8340 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT PUERTO RICO OPERATIONS CO, MED REL |
| Manufacturer Address | ROAD 909, KM. 0.4., BARRIO MAR HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4024 | 2013-06-08 |