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 2015-10-02 for PREVAIL S 8085 manufactured by Medtronic Of Canada.
[27380242]
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27380243]
It was reported that the implantable pulse generator (ipg) did not meet the "pacing for life guarantee" after being implanted for 17 years. The ipg was explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[33167703]
Product event summary: the device was returned and analysis of the device revealed normal battery depletion.
Patient Sequence No: 1, Text Type: N, H10
[102706792]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000024-2015-00002 |
| MDR Report Key | 5122294 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-02 |
| Date of Report | 2015-07-10 |
| Date of Event | 2015-07-10 |
| Date Mfgr Received | 2015-10-09 |
| Date Added to Maude | 2015-10-02 |
| 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 CARDIAC RHYTHM HEART FAILURE |
| 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 | 2015-10-02 |
| Returned To Mfg | 2015-08-24 |
| Model Number | 8085 |
| Catalog Number | 8085 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC OF CANADA |
| Manufacturer Address | 6733 KITIMAT ROAD, MISSISSAUGA ONTARIO L5N 1W3 CA L5N 1W3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-10-02 |