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

Model Number	977D260
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the implantable lead (s/n (b)(4)) found no anomaly.Analysis of the epidural needle found the spoon of the needle had a sharp edge on the undercut side.Concomitant medical products: product id: neu_epiduralneedle, serial# unknown, product type: accessory.Product id: neu_epiduralneedle, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturing representative (rep) regarding a trial patient.Information was reported that a physician inserted curved tip needle, tried to advance then when they tried to pull the lead back out of the needle it wouldn't come back out, so they had to withdraw the needle completely.The caller stated they tried another curved tip needle with the same issue, almost as if the electrodes were catching on the edge of the needle, so it wouldn't go in and out easily.The caller stated they used another lead that worked fine.No further complications were reported.No patient symptoms were reported.Additional information was received from the manufacturer representative.It was reported that the physician could not advance or withdraw the lead through the needle without it hanging up on electrode contacts.It was noted that the cause of this issue was not determined.
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: 7553664
• Report Number: 2649622-2018-08989
• Device Sequence Number: 19129328
• 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
• Report Date (Section B): 10/19/2018

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: 01/09/2022
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR