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

Model Number	977A160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 37714, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 977a260, serial# (b)(4), product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.Information was reported that a patient's pain stimulator broke and the leads broke off.An activity that may be related to the issue includes x-rays.No further complications were reported.No patient symptoms were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Other applicable components are:product id: 37714, serial# (b)(4), implanted: (b)(6) 2014.Product: type: implantable neurostimulator; product id: 977a260, serial# (b)(4), product type lead.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 patient's weight at the time of the event was (b)(6).The leads broke on their own.There was no change in patient's activity.Patient noticed no sensation on right side and saw an hcp who took x-rays and discovered the break.Patient had to have the device removed.Nothing else could be done.A piece broke off and embedded in patient's surrounding muscles.A very large and deep incision had to be made to remove broken piece.No further complications were reported/anticipated.On (b)(6) 2017: no new information.

• Brand Name: VECTRIS SURESCAN
• 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: 6681520
• Report Number: 6000153-2017-00027
• Device Sequence Number: 19347925
• Product Code: LGW
• UDI-Device Identifier: 00643169109421
• UDI-Public: 00643169109421
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 977A160
• Device Catalogue Number: 977A160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 07/17/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/08/2017; 10/05/2017
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 55