MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-22 for ORTHOFIX BONE GROWTH STIMULATOR 5212 655212-0001 manufactured by Orthofix Inc..
[92791230]
Orthofix model 5212 instruction manual states "spinalstim has not been evaluated with regard to use with specific implantable electronic medical devices. Please consult your physician prior to use of the spinastim with implantable electronic medical devices". Medtronic model 3037 information for prescribers manual states " emi from the following equipment is unlikely to affect the neurostimulation system if guidelines are followed. Keep external magnetic field bone growth stimulators 45 cm (18in) away from the neurostimulation system. ".
Patient Sequence No: 1, Text Type: N, H10
[92791231]
Information provided states that during initial treatment with bone growth stimulator patient was physically shocked in her hip area where she has a implanted bladder stimulator, medtronic model 3037. Patient had follow up with urologist and was told that her bladder stimulator had been damaged by the bone growth stimulator. Patient may require revision surgery to repair/replace her bladder stimulator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2017-00027 |
| MDR Report Key | 7053282 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2017-10-05 |
| Date Added to Maude | 2017-11-22 |
| 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 YOLANDA THOMPSON |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE TX 75056 |
| Manufacturer Country | US |
| Manufacturer Postal | 75056 |
| Manufacturer G1 | ORTHOFIX INC. |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE TX 75056 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOFIX BONE GROWTH STIMULATOR 5212 |
| Generic Name | BONE GROWTH STIMULATOR |
| Product Code | LOF |
| Date Received | 2017-11-22 |
| Model Number | 5212 |
| Catalog Number | 655212-0001 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX INC. |
| Manufacturer Address | 3451 PLANO PARKWAY LEWISVILLE TX 75056 US 75056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-22 |