MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

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

Patient Problem Unspecified Infection (1930)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Kirss, j., jr., pinta, t., rautio, t., varpe, p., kairaluoma, m., hyoty, m., hurme, s., bockelman, c., kairaluoma, v., salmenkyla, s., victorzon, m.Impact of sphincter lesions and delayed sphincter repair on sacral neuromodulation treatment outcomes for faecal incontinence: results from a finnish national cohort study.Int j colorectal dis.2018;33(12):1709-1714.Doi: 10.1007/s00384-018-3161-0.Summary: the aim of this multicentre study was to analyse the effects of patent sphincter lesions and previous sphincter repair on the results of sacral neuromodulation (snm) treatment on patients with faecal incontinence (fi).Patients examined by endoanal ultrasound (eaus) with fi as the indication for snm treatment were included in the study.Data was collected from all the centres providing snm treatment in finland and analysed for differences in treatment outcomes.A total of 237 patients treated for incontinence with snm had been examined by eaus.Of these patients, 33 had a history of previous delayed sphincter repair.A patent sphincter lesion was detected by eaus in 128 patients.The eaus finding did not influence the snm test phase outcome (p = 0.129) or the final treatment outcome (p = 0.233).Patient¿s history of prior sphincter repair did not have a significant effect on the snm test (p = 0.425) or final treatment outcome (p = 0.442).Results of our study indicate that a sphincter lesion or previous sphincter repair has no significant effect on the outcome of snm treatment.Our data suggests that delayed sphincter repair prior to snm treatment initiation for fi is not necessary.Reported events: 15 patients experienced an infection during snm testing.(pli 10).

• Brand Name: NEU_INS_STIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8199421
• MDR Text Key: 131501168
• Report Number: 3007566237-2018-03717
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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
• Date Manufacturer Received: 12/13/2018
• 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): Other