MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-05-11 for MICRONY II SR+ 2525T SMTFY999 manufactured by St Jude Medical Cardiac Rhythm Management Division.
[19271704]
It was reported that the pulse generator exhibited loss of capture even at maximum output. The device was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[19423609]
All information provided by manufacturer, no medwatch form was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2011-03067 |
| MDR Report Key | 2084627 |
| Report Source | 01,05 |
| Date Received | 2011-05-11 |
| Date of Event | 2011-02-22 |
| Date Facility Aware | 2011-02-22 |
| Date Mfgr Received | 2011-03-01 |
| Device Manufacturer Date | 2010-04-30 |
| Date Added to Maude | 2011-05-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA MCGRANAHAN |
| Manufacturer Street | 15900 VALLEY VIEW COURT NA |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8184932246 |
| Manufacturer G1 | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION |
| Manufacturer Street | 15900 VALLEY VIEW COURT NA |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRONY II SR+ |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | LWO |
| Date Received | 2011-05-11 |
| Model Number | 2525T |
| Catalog Number | SMTFY999 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2012-04-30 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION |
| Manufacturer Address | 15900 VALLEY VIEW COURT NA SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-11 |