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

Model Number 3058

Device Problems Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Pain (1994); Twitching (2172); Discomfort (2330); Electric Shock (2554)

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

G2: country united kingdom 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.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient with an implantable neurostimulator (ins) is experiencing shocking sensation at the neurostimulator pocket when placing the communicator over the neurostimu lator.The patient lost a lot of weight since last february.However, it is not sure at the moment if the patient for example experienced a fall at the moment or if the shocking sensation is related to the implanted system. in addition to the shocking sensation they also experienced difficulties to find the neurostimulator with the handset/communicator.On 2024-jan-17 additional information was received.The manufacturer representative (rep) reported that healthcare professional (hcp) stated patient was last seen within physiology in september 2023 when colleague made adjustments to patient's programming aiming to alleviate discomfort symptoms in the back region.During today¿s visit, patient reported experiencing ongoing symptoms of perineum and buttock discomfort, as well as discomfort localised just below ribs, despite finding satisfactory symptom control with program one (c1) set at amplitude of 0.7.Additionally, patient disclosed a significant, although steady, weight loss of 40lbs since february 2023, coinciding with persistent muscular symptoms that were previously less noticeable.Patient also expressed difficulties in establishing communication between the battery, communicator, and handset of device.Healthcare professional (hcp) successfully established a connection via the patient's version (my therapy), confirming the device battery's satisfactory status with a displayed green tick.However, attempts to connect the devices in clinician mode were unsuccessful.While the communicator and battery connected, the communicator and handset did not, causing concern.During these attempts, patient reported feeling shocks and muscle twitching in upper right buttock and the top of right leg, coinciding with the side of the battery placement.These sensations were markedly noticeable and caused patient significant pain and discomfort.Despite multiple positioning attempts (standing and sitting), the outcome remained consistent.Upon seeking guidance from the medtronic clinical support helpline, an x-ray was recommended due to weight loss history.Concerns were raised about the potential ingress of fluid into the system, possibly originating from undetermined trauma (although patient denies any slips, trips, or falls).This fluid ingress could potentially cause a short circuit, resulting in the shocks experienced.The suggested x-ray aims to verify the orientation of the sns system.In the event that the x-ray reveals no abnormalities, our proposed plan includes: palpation of the battery site with the sns device turned on, noting patient feedback, palpation of the battery site with the sns device turned off, noting patient feedback, these steps aim to assess the integrity of the system.If inconclusive, medtronic suggested trying a new communicator post-x-ray to ascertain whether similar experiences persist.The hcp request assistance in arranging an x-ray for patient to confirm or rule out the potential causes of patient symptoms.

Event Description

Additional information was received.The manufacturer representative reported xrays were requested.A new communicator to be provided at clinic visit in 2 weeks time.Patient has device currently switched off.No cause known.Palpation at clinic visit did not show any issues with the battery integrity.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18554711
• MDR Text Key: 333510516
• Report Number: 2182207-2024-00241
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/19/2024
• Date Device Manufactured: 11/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male