MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for SURESCAN 97714 manufactured by Medtronic Puerto Rico Operations Co..
[185961396]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185961397]
Information was received from the manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation. It was reported that the patient was currently in the hospital, unrelated to the device or therapy. The rep reported he did not know if the device was dead; possible overdischarge. Hcp wanted to perform an mri of the brain. Pss reviewed that discharged ins was considered off. No symptoms reported. Additional information was received from a rep. The rep reported that an overdischarge was confirmed. The cause was that the patient just stopped charging her device. The rep reported that there was no desire from the patient nor the clinic on any follow up to resolve the issue. The battery remained in overdischarge. There were no plans on the patient? S part to revive the battery. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06479 |
| MDR Report Key | 9908294 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2015-03-23 |
| 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 | SURESCAN |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | LGW |
| Date Received | 2020-03-31 |
| Model Number | 97714 |
| Catalog Number | 97714 |
| Device Expiration Date | 2016-02-14 |
| 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 |