MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for ATTAIN ABILITY MRI SURESCAN 419688 manufactured by Mpri.
[186098610]
Concomitant medical products: c6tr01 crt-p, implanted: (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186098611]
It was reported that the left ventricular (lv) lead was fractured at the lead tip and exhibited two impedance warnings. The lead vector was reprogrammed and remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186210931]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2020-06525 |
| MDR Report Key | 9896716 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2011-06-02 |
| Date Added to Maude | 2020-03-30 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTAIN ABILITY MRI SURESCAN |
| Generic Name | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE |
| Product Code | OJX |
| Date Received | 2020-03-30 |
| Model Number | 419688 |
| Catalog Number | 419688 |
| Device Expiration Date | 2011-09-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-03-30 |