MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-27 for SPF SPINAL FUSION STIMULATOR N/A 10-1335M manufactured by Ebi, Llc..
[3322571]
It was reported that a revision surgery was conducted to remove the implantable stimulator as the patient reported shocking sensation and sudden onset of cauda equina syndrome.
Patient Sequence No: 1, Text Type: D, B5
[10636447]
Current information is insufficient to permit a conclusion as to the cause of the event. Implant date - unknown.
Patient Sequence No: 1, Text Type: N, H10
[10744009]
A visual inspection of the above mentioned customer returned item was performed. A review of the manufacturing record indicates that the unit was manufactured march 2012 with no discrepancies reported at the time of inspection. Functional testing of the returned implantable unit confirms the unit works as intended. Functional testing included but was not limited to the following tests: unit tester light turns on. Output voltage was measured; output current was measured. Returned unit meet all specification as required. No fail condition was found after the investigation. The unit was found to operated/function as intended. Additionally, the design meets the maximum allowable temperature set forth by the iec 60601-1 standard.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2013-00022 |
| MDR Report Key | 3023619 |
| Report Source | 07 |
| Date Received | 2013-03-27 |
| Date of Report | 2013-02-25 |
| Date of Event | 2013-02-20 |
| Date Mfgr Received | 2013-02-25 |
| Device Manufacturer Date | 2012-04-20 |
| Date Added to Maude | 2013-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DAVID TALISH |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer Country | US |
| 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 | SPF-XL IIB 2/DM |
| Product Code | LOE |
| Date Received | 2013-03-27 |
| Returned To Mfg | 2013-02-25 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | 219673 |
| ID Number | N/A |
| Device Expiration Date | 2014-03-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-27 |