MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT TRANSPORT 2CH STIM US STD

Model Number	2783
Medical Device Problem Codes	Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tingling (2171); Electric Shock (2554)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
Complaint received that alleges "shocked the patient, she grabbed the electrode and says that it felt like a cattle prod shocked her.She had an intense headache, shaking and tingling in her left hand".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.No indication event caused or contributed to serious injury, permanent impairment or death.

• Brand Name: CHATTANOOGA
• Common Device Name: INTELECT TRANSPORT 2CH STIM US STD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6554312
• Report Number: 9616086-2017-00008
• Device Sequence Number: 1033484
• Product Code: IMI
• UDI-Device Identifier: 00888912293945
• UDI-Public: 00888912293945
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K973024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: Other
• Device Model Number: 2783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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