MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-08-13 for MINIX 8341M manufactured by Medtronic Canada Dist Ctr.
[2859866]
It was reported the device was unresponsive to telemetry. Pacing was said to be "erratic" with magnet. When asked, the patient did remember a "vibrating" sensation in or around the pocket site. The device will be removed. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10167474]
This event occurred outside the us. All information provided is included in this report. If additional relevant information is received, a supplemental report will be submitted. Patient information is not generally available due to confidentiality concerns.
Patient Sequence No: 1, Text Type: N, H10
[22562617]
.
Patient Sequence No: 1, Text Type: N, H10
[28650290]
Product event summary : the device was returned and analyzed. Analysis of the device revealed normal battery depletion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000024-2012-00017 |
| MDR Report Key | 2694607 |
| Report Source | 01,05,07 |
| Date Received | 2012-08-13 |
| Date Mfgr Received | 2015-08-19 |
| Date Added to Maude | 2012-08-13 |
| 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 8200 CORAL SEA ST. N.E. |
| 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 |
| 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 | 2012-08-13 |
| Returned To Mfg | 2015-06-08 |
| Model Number | 8341M |
| Catalog Number | 8341M |
| 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 CANADA DIST CTR |
| 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 | 2012-08-13 |