MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for ATTAIN OVER THE WIRE LEAD 419378 manufactured by Mpri.
[185224034]
Product event summary: the partial lead was returned in segments, analyzed. Analysis indicated the distal conductor of the lead developed a fracture due to flexing while in vivo. Concomitant medical products: 6949, lead, implanted: (b)(6) 2004. 4269, lead, implant: (b)(6) 1993. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185224035]
It was reported that there was no alleged product issue with the left ventricular (lv) lead as it was explanted when the patient underwent open heart surgery. The lv lead was returned to the manufacturer, analyzed, and subsequently tested out of specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2020-06386 |
| MDR Report Key | 9888101 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2004-03-31 |
| Date Added to Maude | 2020-03-27 |
| 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 OVER THE WIRE LEAD |
| Generic Name | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE |
| Product Code | LWP |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 419378 |
| Catalog Number | 419378 |
| Device Expiration Date | 2006-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-27 |