MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for SURESCAN 97714 manufactured by Medtronic Puerto Rico Operations Co..
[188597118]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188597119]
Information was received by a patient via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that the patient noticed they were not able to charge? Months ago,? But the patient had a death occur of someone they know and they didn? T stay compliant and their device was overdischarged. The rep stated that they were with the patient and had the ins charging now with six coupling boxes. The caller wanted to know how long they had to charge before the clinician programmer would connect to clear the por (power on reset) as they needed to leave. Technical services reviewed information and emailed instructions on how to clear the por with the patient programmer if necessary. The event occurred in 2019. Additional information was reported that the patient's overdischarge was not resolved. The patient's ins will be replaced, but has not been scheduled yet. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06471 |
| MDR Report Key | 9907731 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2017-05-23 |
| 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 | 2018-04-14 |
| 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 | 1. Required No Informationntervention | 2020-03-31 |