MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-13 for VECTRIS SURESCAN 977A260 manufactured by Mpri.
[183283006]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183283007]
It was reported that the lead was providing stimulation in the left leg more than the primary area of pain which was the right leg and hip. The patient had only one octad lead. Reprogramming was initially successful to recapture coverage and provide pain relief, however, the patient reported that pain relief was minimal compared to their trial. Reprogramming was beneficial but the patient reported now that it helped initially but then worsened again. Consultation with neurosurgery was being done for paddle lead placement. The issue hadn? T resolved, and surgical intervention was planned but not scheduled.
Patient Sequence No: 1, Text Type: D, B5
[188143974]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188143975]
Additional information was received from the rep. It was reported that the cause was not determined. The surgery date was not set at the time. Rep will provide update once available. The provided information was confirmed with the physician/account.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2020-05253 |
| MDR Report Key | 9829544 |
| Report Source | CONSUMER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-10-03 |
| Date Added to Maude | 2020-03-13 |
| 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 | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| 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 | VECTRIS SURESCAN |
| Generic Name | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) |
| Product Code | GZB |
| Date Received | 2020-03-13 |
| Model Number | 977A260 |
| Catalog Number | 977A260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-13 |