MAUDE Adverse Event Report: ORTHOFIX INC. ORTHOFIX BONE GROWTH STIMULATOR 5212

Model Number	5212
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.".
Event or Problem Description
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.

• Brand Name: ORTHOFIX BONE GROWTH STIMULATOR 5212
• Common Device Name: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 7053282
• Report Number: 2183449-2017-00027
• Device Sequence Number: 2037567
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5212
• Device Catalogue Number: 655212-0001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR