MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-06-10 for PREVAIL S 8086B manufactured by Mdt Puerto Rico Operations Co, Med Rel.
[17929597]
It was reported that an infection and erosion occurred. The implantable pulse generator (ipg) system was explanted. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[18096642]
Product event summary: analysis of the returned device was not performed but the device met the expected longevity. 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 | 2647346-2014-00047 |
| MDR Report Key | 3863062 |
| Report Source | 05,07 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-01-16 |
| Date of Event | 2014-01-16 |
| Date Mfgr Received | 2014-01-16 |
| Device Manufacturer Date | 1998-10-05 |
| Date Added to Maude | 2014-06-11 |
| 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 | PREVAIL S |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2014-06-10 |
| Returned To Mfg | 2014-02-03 |
| Model Number | 8086B |
| Catalog Number | 8086B |
| Device Expiration Date | 2000-03-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 4068 | 1. Hospitalization; 2. Required No Informationntervention | 2014-06-10 |