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

Model Number	977D160
Medical Device Problem Codes	High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #0 and #4 conductors were broken; 4.1 cm from the distal end of the lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a trial patient who was using an external neurostimulator (ens) for unknown indications for use.It was reported that rep reports hcp doing a trial this morning but rep got oor, and impedance seems to stay inconsistently high.Rep said initially connectivity was all red as well as impedance check, hcp switch lead to another wens channel but got the same result.Hcp then used another wens but got the same result as well, eventually a couple electrodes came back with impedance around 2300 ohms.Hcp then used another lead and he got similar results again.Rep said hcp would move the lead within the wens ever so slightly and impedance would change, and at one point hcp got up to 3 electrodes to come in that isn't red.Rep said hcp just never got reliable connectivity.Rep said he was able to get some stimulation down the leg.Hcp eventually decided the impedance wasn't consistent enough and he abandoned the trial.Rep said hcp used loss of resistance with air to insert the needle.Discussed how air can cause impedance to fluctuate.Rep did run stimulation but there was not enough change in impedance.Rep to send wens (wireless external neurostimulator) and leads back for analysis.The rep reported that the cause of the high impedances are unknown.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 12229657
• Report Number: 2649622-2021-14988
• Device Sequence Number: 3807420
• Product Code: LGW
• UDI-Device Identifier: 00763000006563
• UDI-Public: 00763000006563
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 07/09/2022
• Device Model Number: 977D160
• Device Catalogue Number: 977D160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR