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

Model Number 5212

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 10/16/2017

Event Type  Injury  

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 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
• Type of Device: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056
• MDR Report Key: 7053282
• MDR Text Key: 92791230
• Report Number: 2183449-2017-00027
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5212
• Device Catalogue Number: 655212-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR