MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for VERSA IPG VEDR01 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[185718893]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185718954]
It was also reported that the implantable pulse generator (ipg) wound site experienced an extensive hematoma. It also was reported that the right ventricular (rv) lead malfunction and experienced high thresholds. The ipg hematoma required intervention and the rvlead was capped and replaced. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06449 |
| MDR Report Key | 9903398 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2008-05-06 |
| 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 | VERSA IPG |
| Generic Name | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
| Product Code | NVZ |
| Date Received | 2020-03-31 |
| Model Number | VEDR01 |
| Catalog Number | VEDR01 |
| Device Expiration Date | 2009-10-28 |
| 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 | 5076 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |