MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885)

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

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 the manufacturer representative inquired about "*" for a new stimulator message on the clinician programmer after they performed a battery test.It was reviewed that for the patient's ins model, it must have gone into a power-on-reset (por).The caller indicated the patient came into the clinic with stimulation on and did not see a por message.The caller was fairly new to the manufacturing company and indicated it must have been the previous representative who encountered the por.The longevity screen change due to por was reviewed and the representative wanted clarification on the best way to calculate longevity.They were advised to use a combination of old and new amplitudes to be conservative.The patient was previously on 3.5 volts on program four and was now at 2.0 volts.No symptoms nor patient complications were reported and troubleshooting resolved the reported issue.

Manufacturer Narrative

Correction: b5: event description corrected and resubmitted to include patient's indications for use in first sentence."information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor." 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.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the manufacturer representative inquired about "*" for a new stimulator message on the clinician programmer after they performed a battery test.It was reviewed that for the patient's ins model, it must have gone into a power-on-reset (por).The caller indicated the patient came into the clinic with stimulation on and did not see a por message.The caller was fairly new to the manufacturing company and indicated it must have been the previous representative who encountered the por.The longevity screen change due to por was reviewed and the representative wanted clarification on the best way to calculate longevity.They were advised to use a combination of old and new amplitudes to be conservative.The patient was previously on 3.5 volts on program four and was now at 2.0 volts.No symptoms nor patient complications were reported and troubleshooting resolved the reported issue.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11143157
• MDR Text Key: 226014181
• Report Number: 3004209178-2021-00458
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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: 01/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1