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

Model Number	977C290
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
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 regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that intra-op after placing a surgical lead they were unable to insert the left lead into either of the header block openings.They were unable to get the first electrode intothe header block.The other leg of the lead went into both header blocks fine.Initially when asked the lead did not look damaged or different, however when the healthcare provider looked closer it was noted the lead/distal electrode appeared flatter than the other electrodes.The caller stated nothing occurred to the lead during the procedure to cause the issue.Lubricating the lead did not resolve the issue.The lead was replaced with a different lead.No symptoms were reported.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11560767
• Report Number: 2182207-2021-00511
• Device Sequence Number: 3071927
• Product Code: LGW
• UDI-Device Identifier: 00643169464667
• UDI-Public: 00643169464667
• 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): 03/24/2021

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: 03/30/2021
• Device Model Number: 977C290
• Device Catalogue Number: 977C290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR