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

Model Number	977A275
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Twitching (2172)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 97713, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.
Event or Problem Description
The manufacturer representative reported that x-ray shows that the lead had pulled down and into the ¿guter¿ or lateral area of the epidural space.It was reported that the patient started to have stimulation in side and made twitching in side.Impedance was checked and x-ray done.The representative was able to turn off the lead that had moved and get all the areas of pain covered with on lead that still was in place.The patient was reported happy after reprogramming.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6219804
• Report Number: 2649622-2017-00003
• Device Sequence Number: 716834
• Product Code: LGW
• UDI-Device Identifier: 00643169109384
• UDI-Public: 00643169109384
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR