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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Rubio-perez, i., saavedra, j., marijuan, j.L., pascual-miguelanez, i.Optimizing sacral neuromodulation for low anterior resection syndrome: learning from our experience.Colorectal dis.2020.Doi: 10.1111/codi.15261.Summary: the aim of this work was to review our institutional series of patients treated with sacral neuromodulation (snm) for low anterior resection syndrome (lars) and evaluate possible factors associated with therapeutic success.Method twenty-five patients were treated with snm for lars between 2008 and 2019.Snm was performed as per our institutional protocol.Patients were evaluated with wexner and lars scores before and after snm treatment.A visual analogue scale (1¿10) was used to evaluate overall patient satisfaction with snm.There were significant differences between the mean lars score values before (37.82) and after (29) snm therapy (p < 0.004).The mean wexner score was higher (16.24) before snm treatment than afterwards (11.13) (p < 0.004).There was a direct relationship between the height of anastomosis and lars score (p = 0.035): there were big changes in lars scoring (pre-/post-snm therapy) in patients with higher anastomoses, and vice versa.Patients who received radiotherapy scored lower in mean satisfaction (6.38) than patients without previous radiotherapy (8.22) (p = 0.008).There was an important positive association between wexner score and patient satisfaction (p = 0.001): relevant changes in wexner scoring after snm therapy were associated with high patient satisfaction, and vice versa.Our study showed a relationship between changes in wexner and lars scores before and after snm and overall patient satisfaction with snm therapy.These findings also suggest patients with previous radiotherapy may have worse results with snm (based on lower overall satisfaction), and that higher anastomoses have a greater impact on the post-snm lars score.Reported events: it was reported that one patient (4%) experienced an infection.One patient (4%) experienced a loss of effect and their device was explanted.One patient (4%) experienced pain and their device was explanted.One patient (4%) experienced an extrusion and underwent a revision.One patient (4%) experienced pain and underwent a revision.No specific device information provided.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10839233
• MDR Text Key: 218515719
• Report Number: 2182207-2020-01274
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/13/2020
• 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 Outcome(s): Required Intervention