MAUDE Adverse Event Report: NEURO - VILLALBA SPECIFY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	39565-65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Rash (2033)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient with an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient had their ins explanted on (b)(6) 2017 to switch over to a competitor¿s device.It was noted that the ins was removed, but the paddle lead was left in and the patient started a trial with the competitor¿s ins the same day.The patient ended up getting a severe staph infection and the patient was getting allergy testing because they had rashes all over their back.No further complications are anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the patient.It was reported that the staph infection resulted from the surgery and an allergic reaction to dermabond.It was reported that the device was removed and the patient was administered antibiotics.The issue was resolved and no further complications are anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 7433055
• Report Number: 6000153-2018-00007
• Device Sequence Number: 109194
• Product Code: LGW
• UDI-Device Identifier: 00613994560322
• UDI-Public: 00613994560322
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2019
• Device Model Number: 39565-65
• Device Catalogue Number: 39565-65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 06/04/2018; 07/05/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 06/14/2018; 07/05/2018
• 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: Required Intervention
• Patient Age: 53 YR