MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 978B128

Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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  an intra-op issue with the lead that occurred yesterday.Caller reported a lead replacement and during implant, after correct lead placement and while removing the lead introducer sheath, the lead was being removed as well.Per physician it felt like the sheath was sticking to the lead.The physician did grasp the lead to prevent removal, but it appeared like something either on the lead or sheath were grabbing and unable to keep the lead in place.The physician and rep believed there may be blood inside the introducer sheath, so they removed sheath, lead and cleaned off and then attempted to implant the lead again, only to have the lead come back with the sheath.While discussing, the only thing greater in diameter would be the tines on the lead, the caller then indicated it could appear as if a few of the tines are not positioned correctly.When asked if previous insertion without  issue occurred prior to this event, the caller indicated the difficulty removing lead from sheath occurred immediately, no other insertion/removal attempts were performed.The physician attempted to remove the lead multiple times (15x times) to attempt to save the lead.They did resolve this issue by replacing the lead and sheath.Caller will be returning lead and sheath for analysis.

Manufacturer Narrative

H3: the returned lead was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.The returned unknown sheath was subjected to a series of standard tests that include but is not limited to visual inspection and functional testing.Analysis identified that the lead introducer sheath was damaged.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the returned lead was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.The returned unknown sheath was subjected to a series of standard tests that include but is not limited to visual inspection and functional testing.Analysis identified that the lead introducer sheath was damaged.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12406964
• MDR Text Key: 271706593
• Report Number: 2182207-2021-01503
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203726
• UDI-Public: 00763000203726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2F5RS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 10/28/2021
• Supplement Dates FDA Received: 11/23/2021; 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Age: 74 YR
• Patient Sex: Female