MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-30 for ATTAIN LV 2187-75 manufactured by Mpri.
[186674225]
Concomitant medical products: dtma1d1 crt-d, implanted: (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186674226]
It was reported by the patient's family member that the device always protruded out since implant. Now, "the skin is so thin and the device is coming out". They also noted that the patient had a (b)(6). The cardiac resynchronization therapy defibrillator (crt-d) system was subsequently explanted due to the infection and device erosion. During the explant procedure when attempting to extract the right ventricular (rv) lead, the superior vena cava (svc) coil was pulling apart and a partial tear of the svc was noted on transesophageal echocardiogram (tee). The rv lead was partially explanted. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188155113]
Product event summary: the partial lead was returned in segments and analyzed. Analysis indicated the outer insulation of the lead developed a breach due to environmental stress cracking while in vivo. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2020-06587 |
| MDR Report Key | 9899360 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2020-03-10 |
| 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 LV |
| Generic Name | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE |
| Product Code | LWP |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-18 |
| Model Number | 2187-75 |
| Catalog Number | 2187-75 |
| Device Expiration Date | 2003-09-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |