MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-23 for IMPLANTABLE SPINAL FUSION STIMULATOR 10-1335M manufactured by Ebi, Llc.
[20395002]
The instructions for use indicate that in randomized and non-randomized clinical studies involving 493 patients using the model spf-4, twenty-two adverse events (4%) were reported; of which 5 were for reported infection.
Patient Sequence No: 1, Text Type: N, H10
[20413116]
It was reported by the physician that the patient experienced a wound infection at the subcutaneous tissue where the battery was placed. The battery was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-2011-00114 |
| MDR Report Key | 2261672 |
| Report Source | 05 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-25 |
| Date Mfgr Received | 2011-08-30 |
| Device Manufacturer Date | 2011-08-08 |
| Date Added to Maude | 2011-09-23 |
| 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 | ART KAUFMAN |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE SPINAL FUSION STIMULATOR |
| Generic Name | STIMULATOR, 10-1335M |
| Product Code | LOE |
| Date Received | 2011-09-23 |
| Catalog Number | 10-1335M |
| Lot Number | 218106 |
| Device Expiration Date | 2013-05-05 |
| 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 | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-23 |