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 SURESCAN 97714 manufactured by Medtronic Med Rel Medtronic Puerto Rico.
[185970504]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185970505]
Information was received from a patient with an implantable neurostimulator (ins). It was reported that when the patient would get up from sitting, they would get a shock right above their ins. The patient stated that their ins location is near their hip, within four to five inches. The patient reported that when they would bend a certain way, they would experience a jab feeling, almost like a wire was loose and jabbing into their skin. It was confirmed by the patient that there were no falls or traumas that may have led or contributed to the issue and has not changed their stimulation. It was noted that the issue had been going on for about two weeks. It was recommended that the patient meet with their healthcare provider (hcp) to check their ins. No further complications were reported/anticipated. Indication for use is non-malignant pain.
Patient Sequence No: 1, Text Type: D, B5
[188933293]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188933294]
Additional information received from the consumer reported that the issue had been gradually coming on. The patient stated that she would occasionally get severe pain around the battery. The patient had tried turning off stimulation to see if it was something else but the shocking only happened when the stimulator was on. The issue was not resolved and the patient noted that the battery was 7 years old and they would go with it until it died because they had been denied a replacement by their insurance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06480 |
| MDR Report Key | 9908444 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2013-11-12 |
| 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 MED REL MEDTRONIC PUERTO RICO |
| 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 | 2014-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
| 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 |