MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for SURESCAN 97714 manufactured by Medtronic Puerto Rico Operations Co..
[72596894]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[72596895]
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain. It was reported that there was a change in therapy. The patient was getting into the car and had fallen right on his back. The family member/friend of the patient had the patient programmer and turned the stimulator on after the fall and everything was okay and everything was good. An ambulance came; however the patient didn? T want to go to the hospital. The patient had just gone to the pain specialist on (b)(6) 2017 to get the device readjusted. It was reviewed that the only way to tell if the device was alright was to have the health care provider check the device. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[74527550]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[74527551]
Additional information was received from a consumer reporting that the patient fell and twisted their knee on the (b)(6) and went to the emergency room on the (b)(6). The caller also asked about mri compatibility guidelines for a procedure unrelated to the device or therapy. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[102522471]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2017-08032 |
| MDR Report Key | 6481672 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2015-10-13 |
| Date Added to Maude | 2017-04-11 |
| 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 | SURGICAL TABLE CUSHION |
| Product Code | LWG |
| Date Received | 2017-04-11 |
| Model Number | 97714 |
| Catalog Number | 97714 |
| Device Expiration Date | 2016-08-28 |
| 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 | 2017-04-11 |