MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-18 for SPF-XL IIB 2/DM IMPLANTABLE STIMULATOR N/A 10-1335M manufactured by Biomet Spine - Broomfield.
[33906587]
No device evaluation is able to be performed as the device remains implanted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event, however based on the information provided the pain is due to the patient's si joint. 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
[33906588]
The patient reported she had an implantable stimulator implanted in 1997 after l3-l5 fusion. She reports the stimulator has been implanted 18 years although she read in the brochure that "the generator may optionally be removed at the end of its useful life (approximately 24-weeks). " she reports following up with her physician in 2003, however he chose not to remove the device even though she was experiencing pain. She further reports having "other fusions in the cervical area of the spine. " she reports seeing a pain management doctor for continuing lower back pain who referred her to a neuro surgeon. She stated the neurosurgeon believes her problem is in her si joint (sacroiliac joint) and is not related to the bone stimulator. She states the surgeon plans to giver her an injection to reduce the swelling; she is unaware of the type of injection and did not have an appointment set at the time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2015-00115 |
| MDR Report Key | 5311652 |
| Report Source | CONSUMER |
| Date Received | 2015-12-18 |
| Date of Report | 2015-08-18 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-12-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | BIOMET SPINE - BROOMFIELD |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-XL IIB 2/DM IMPLANTABLE STIMULATOR |
| Generic Name | STIMULATOR |
| Product Code | LOE |
| Date Received | 2015-12-18 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | UNKNOWN |
| 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 | BIOMET SPINE - BROOMFIELD |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-18 |