MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for SPECIFY SURESCAN 977C265 manufactured by Mpri.
[184377871]
Updated/corrected to reflect "none" as no patient was involved in this event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184441278]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184441279]
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that when the rep went to use the lead and opened it (the packaging), they questioned the sterility due to the state of the box as the seal around the edge had been breached and due to the edges of the lead. They weren't sure if the lead was still sterile and they didn't want to take a chance, so they decided they would return the lead to the manufacturer for analysis. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[188990345]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188990346]
Additional information received from the manufacturer representative reported that the box looked damage and the edge of the lead packaging looked dark like it may have been wet at some point. It was noted that the lead was part of their trunk stock and not from an account.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2020-05781 |
| MDR Report Key | 9862832 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2016-06-16 |
| Date Added to Maude | 2020-03-20 |
| 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 | SPECIFY SURESCAN |
| Generic Name | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) |
| Product Code | GZB |
| Date Received | 2020-03-20 |
| Model Number | 977C265 |
| Catalog Number | 977C265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-20 |