MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3889-28
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative (rep) that the torque wrench did not click when the screw was tightened down the extension.The rep noted it just continued to rotate with no audible sound.There were no environmental, external, or patient factors that may have led or contributed to the issue.The rep noted the hcp continued to try the screwdriver on other set screws on the extension.The hcp backed out of the screws, a new torque wrench was provided and that wrench made the audible click.The issue was resolved at the time of the report.There were no further complications that have been reported as a result of this event.The patient is implanted for gastrointestinal/pelvic floor.
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 3550-80, product type: accessory.(b)(4).
Event or Problem Description
Additional information from the healthcare professional (hcp) reported via a manufacturer representative (rep) that they were not sure of the patient¿s weight, but they were not obese.It was noted the torque wrench was in the lead kit.There were no further complications that have been reported as a result of this event.
Additional Manufacturer Narrative
Analysis information -- (b)(6) 2017 17:37:46 cst pli# 30 product id# 3550-80 analysis determined that the torque wrench was out of specification.A torque test was performed on the returned wrench.The returned wrench measured 5.8 oz-in, not meeting the specification of 5 oz-in +/- 0.5 oz-in.Section d information references the main component of the system and other applicable components are: product id 3550-80, product type accessory.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 6562743
• Report Number: 3007566237-2017-01833
• Device Sequence Number: 616250
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/27/2022

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: 03/06/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1F7W4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 08/18/2017; 08/18/2017; 07/27/2022
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 05/23/2017; 06/26/2017; 08/18/2017; 10/04/2017; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 53 YR
• Patient Sex: Female