MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PROTECTA XT DR D314DRG manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[185730441]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185730442]
It was reported that the patient was inappropriately shocked by the implantable cardioverter defibrillator (icd) after detecting an atrial driven arrhythmia where anti-tachycardia pacing (atp) induced ventricular tachycardia (vt). The patient also had multiple episodes of non-sustained ventricular tachycardia (ns-vt) where the icd stability algorithm inappropriately withheld therapy. The stability algorithm was programmed off. The patient was medically treated. The icd remains in use. The patient is enrolled in a clinical study. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06409 |
| MDR Report Key | 9903707 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2013-08-08 |
| Date Added to Maude | 2020-03-31 |
| 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 | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTECTA XT DR |
| Generic Name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Product Code | LWS |
| Date Received | 2020-03-31 |
| Model Number | D314DRG |
| Catalog Number | D314DRG |
| Device Expiration Date | 2015-01-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4076 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-31 |