MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-08-15 for IMPLANTABLE STIMULATOR N/A UNKNOWN manufactured by Ebi, Llc..
[2863933]
Per medwatch report (b)(4), "pt had a spinal fusion in 2007. A bone stimulator was implanted with lead into the spine. " "the stimulator stopped working and had to be removed in 2008. The lead still remained in the spine. " "patient discovered that the bone stimulator caused the complained of personal injuries. Patient discovered about the effects while researching online. " "patient has suffered: neurological damages, pain and suffering. " the allegations of the complaint are unverified.
Patient Sequence No: 1, Text Type: D, B5
[10122012]
Information recieved via medwatch report (b)(4). No product was returned to manufacturer. Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[19784802]
No visual or functional evaluation could be performed to independently verify reported incident. Likewise, without a part and lot number, a review of the manufacturing record could not be performed to check of dimensional, functional, or material anomalies at time of inspection. The probable underlying root cause for the reported incident may be related to the patient with the device being subjected to mri testing at 3 tesla. Tesla (t) is the unit of measurement quantifying the strength of a magnetic field. Prior to the introduction of 3 tesla machines in the late 1990s, the high-field standard was 1. 5 tesla. 3t scanners generates a magnetic field that is twice the strength of 1. 5 tesla machines and 10 to 15 times the strength of low field or open mri scanners. Due to the high magnetic field generated by 3t scanners, the spf manual (p/n 196260l) states: "a patient with a spf-plus 60/w or 60/m may safely undergo an mri procedure using a shielded mr system with a static magnetic field of 1. 5 tesla or less (maximum spatial gradient 250 gauss/cm). " the manual continues, "spf-plus 60/w and 60/m that underwent testing passed the astm acceptance criteria for deflection angle with respect to exposure to the 1. 5-tesla mr system used in this evaluation. Thus, these devices will not present an additional risk or hazard to a patient in the 1. 5-tesla mri environment with regard to translational attraction or migration. " likewise similar information is also included in the spf xlib manual (196201l) stating: "experiments conducted to assess magnetic field interactions, artifacts, and operational aspects of the implantable spinal fusion stimulators combined with experience in patients indicate that mr procedures may be performed safely in patients using mr systems of 1. 5 tesla or less (maximum spatial gradient 450 gauss/cm) following specific recommendations and precautions. " additionally, the patient travel and mri card states: "the ebi spf spinal fusion stimulator has received fda approval for the claim of mri safe for the spf-2t and spf-xl iib models when used in mr environments up to 1. 5 tesla. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2012-00055 |
| MDR Report Key | 2699680 |
| Report Source | 00 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Date Added to Maude | 2012-08-15 |
| 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 | IMPLANTABLE STIMULATOR |
| Generic Name | IMPLANTABLE STIMULATOR |
| Product Code | LOE |
| Date Received | 2012-08-15 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2012-08-15 |