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

Model Number	977A290
Medical Device Problem Codes	Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 97715, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) non-malignant pain.It was reported that the an explant procedure was performed on (b)(6) 2018.The doctor attempted to explant a suborbital lead.When they pulled on the lead from the incision on the side of the patient's face, the lead broke resulting in six contacts remaining in the patient.The rest of the broken lead will be returned to the manufacturer for analysis.The lead was replaced on (b)(6) 2018, which resolved the reported issues.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Product id: 97715, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the manufacturer representative on (b)(6) 2018-jun-01.It was noted that the hospital protocol was to keep the explant so the lead was not returned.No further complications were reported.
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 manufacturer representative on (b)(6) 2018 confirming that the patient was now getting excellent therapy.No further complications were reported.

• Brand Name: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7546034
• Report Number: 2649622-2018-08856
• Device Sequence Number: 1453047
• Product Code: LGW
• UDI-Device Identifier: 00643169109377
• UDI-Public: 00643169109377
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2018

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: 11/12/2019
• Device Model Number: 977A290
• Device Catalogue Number: 977A290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/01/2018; 06/10/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 06/08/2018; 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR