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

Model Number	977D260
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
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 manufacturer representative (rep) regarding a trial patient being implanted with an unknown spinal cord stimulator model.It was reported that on (b)(6) 2018 during a trial lead implant procedure, the trial lead was damaged; an electrode looked like it had broken off of the lead when the doctor was deploying the lead from the needle/introducer.The doctor decided to use another lead.No symptoms were reported.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Device conclusion code does not apply.Device result code does not apply.Device method code.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer representative regarding the patient.It was reported that the physician deployed the lead and he rotated the needle.It appeared that the top electrode had bent back and almost looked as if it had broken off.The lead was removed.There were no patient symptoms or complications reported.
Additional Manufacturer Narrative
Analysis of the lead (b)(4).Found that the tip of the distal end was bent.Product analysis (b)(4):analysis information -- 2018-09-14 11:35:11 cst pli# 10 product id# 977d260 below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis identified the {x} electrode at the distal end of the lead was bent.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.{the lead and stylet wire are both severely bent on the distal side of the #1 electrode.} product id 3550-32 product type accessory product id neu_stylet_acc product type accessory.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: 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: 7683116
• Report Number: 2649622-2018-11351
• Device Sequence Number: 1018614
• Product Code: LGW
• UDI-Device Identifier: 00643169118249
• UDI-Public: 00643169118249
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 05/24/2022
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 09/14/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/16/2018; 09/18/2018; 10/03/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1