MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-01 for SPF PLUS-MINI (60 ?A/W) N/A 10-1398M manufactured by Ebi, Llc..
[143671147]
(b)(4). Implant date: device was implanted in (b)(6) 2015. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[143671148]
It was reported that the patient has issues with that spf unit. She states that she feels like something is wrong, and that she is experiencing pain in the area where the unit is implanted. She states that her pain level is 5-7 on a scale of 1-10. She states that no part of the unit has been explanted and she can feel the unit. The patient spoke to her surgeon who stated that she "shouldn't be able to feel it". She stated that she has tried to have an mri scan, but has been turned down by 3 facilities due to mri safety information found online. The patient refused the offer of the spf physician manual which includes mri safety information, and is currently searching for a new doctor. The unit still remains implanted in the patient at this time. No known adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00011 |
| MDR Report Key | 8568340 |
| Report Source | CONSUMER |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-29 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2015-04-24 |
| Date Added to Maude | 2019-05-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHAAN POLIUS |
| 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 PLUS-MINI (60 ?A/W) |
| Generic Name | SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
| Product Code | LOE |
| Date Received | 2019-05-01 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| 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. Other | 2019-05-01 |