MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-30 for SPF SPINAL FUSION STIMULATOR N/A 10-1335M manufactured by Ebi, Llc..
[6059237]
The original surgery was performed (b)(6) 2014 and a implantable stimulator was placed. The patient reported having an mri on (b)(6) 2014; he states the radiologist informed him that he never performed an mri with this stimulator and advised the patient to hit the button if he felt anything. The patient said he could not feel any pain during the mri, however a couple days later he began experiencing pain and electrical shock sensation. The patient followed up with his physician who subsequently explanted the stimulator on (b)(6) 2015. The patient reports the symptoms subsided after the device was explanted.
Patient Sequence No: 1, Text Type: D, B5
[13527599]
The package insert has a section titled "mri safety information, artifacts testing and efficacy" which has instructions for mri procedures and states "the effects of mri procedures using mr systems and conditions above these levels have not been determined. " review of device history records show that lot released with no recorded anomaly or deviation. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2015-00064 |
| MDR Report Key | 4879042 |
| Report Source | 04 |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-03-19 |
| Date Mfgr Received | 2015-06-02 |
| Device Manufacturer Date | 2014-04-24 |
| Date Added to Maude | 2015-07-01 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer G1 | EBI, LLC. |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF SPINAL FUSION STIMULATOR |
| Generic Name | IMPLANTABLE STIMULATOR |
| Product Code | LOE |
| Date Received | 2015-06-30 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | 221475 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-06-30 |