MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-09 for CAPSUREFIX NOVUS MRI 5086MRI52 manufactured by Mpri.
[16915735]
It was reported that during the implant attempt, the lead was continually folding over itself (due to difficult anatomy) while the physician was trying to place the lead. The physician decided to re-stick and was able to get the lead into the ventricle. After testing the lead through the analyzer, there was no sensing, impedance values were low and there was no output. The initial manipulation may have damaged the lead. The lead was not used and a new lead was implanted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[16998240]
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 | 2649622-2013-00192 |
| MDR Report Key | 2951722 |
| Report Source | 05,07 |
| Date Received | 2013-02-09 |
| Date of Report | 2012-11-05 |
| Date of Event | 2012-11-05 |
| Date Mfgr Received | 2012-11-05 |
| Device Manufacturer Date | 2012-08-24 |
| Date Added to Maude | 2013-04-23 |
| 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 | RICHARD ROY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635262574 |
| 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 | CAPSUREFIX NOVUS MRI |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, DUAL-BALLOON |
| Product Code | NVM |
| Date Received | 2013-02-09 |
| Model Number | 5086MRI52 |
| Catalog Number | 5086MRI52 |
| Device Expiration Date | 2014-08-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-09 |