MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for INTELLIS 97715 manufactured by Medtronic Puerto Rico Operations Co..
[185962120]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185962121]
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins). It was reported that the patient? S ins was not working at all, which was clarified further to mean the ins was not providing them relief. The patient stated that the ins was not stopping the spasms and the ins was shocking them like crazy. The patient noted trying group a, b and c that they had available. The patient stated that the last time they charged the ins and stopped using the ins was this month, (b)(6) 2020. The patient was calling in for assistance with accessing mri mode. Patient services began walking the patient through accessing mri mode when the patient saw the? No device found? Error message on the controller. Patient services stated that the ins battery was dead and they hadn? T charged the ins. Patient services had the patient connect the recharger to the controller and start an ins charging session. The patient confirmed seeing recharging with excellent recharge quality. Patient services reviewed that the ins must be charged to at least 30 percent in order the ins to be turned on and access mri mode. The patient would call back once the ins was charged enough to be walked through accessing mri mode. The event occurred in (b)(6) 2020. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06477 |
| MDR Report Key | 9908163 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-01-21 |
| 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 | 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 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| 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 | INTELLIS |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | LGW |
| Date Received | 2020-03-31 |
| Model Number | 97715 |
| Catalog Number | 97715 |
| Device Expiration Date | 2020-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |