MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Material Deformation (2976)

Patient Problems Electric Shock (2554); Twiddlers Syndrome (4563); Insufficient Information (4580)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot# unknown, product type: lead, other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Haslam, m., parkman, h.P., petrov, r.V.Absorbable antibacterial envelope in the surgical management of twiddler's syndrome in a patient with gastric electric stimulator: a case report.Dig med res.2020 doi: 3.10.21037/dmr-20-70.Summary: gastroparesis is a chronic gastric motility disorder characterized by delayed gastric emptying and a multitude of troublesome symptoms, including chronic nausea, vomiting, abdominal pain, malnutrition, and dehydration.Whereas initial management of the ga stroparesis is conservative, patient with refractory gastroparesis may benefit from surgical therapy, including gastric electric stimulator (ges) device implantation.Twiddler¿s syndrome is a challenging condition well described in the cardiac literature that is characterized by the instability, displacement, leads twisting and resulting malfunction of an implanted device, believed to be due to manipulation (twiddling) by the patient.The condition is not specifically characterized in the ges literature; however, evidence suggest the incidence of the twiddler¿s syndrome is reaching up to 9% of the patients with ges.In the current report we present a case of surgical management of the recurrent twiddler¿s syndrome in a patient with a ges device with novel non-fda approved use of the tyrx¿ absorbable antibacterial envelope for the device stabilization.Use of the tyrx¿ enveloped provided additional anchoring points of fixation, resulting in the successful resolution of the device instability and the twiddler¿s syndrome with and ongoing follow up of up to 8 months.This report adds to the armamentarium of surgical management of this uncommon and difficult problem.Reported events: a (b)(6) year-old obese woman with refractory diabetic gastroparesis underwent re-implantation of a ges 14 months after explantation of a previous device due to need of mri.Initially she was doing well until her symptoms of nausea, vomiting and abdominal pain have returned 4 months postoperatively.Interrogation of the device revealed abnormal impedance values.Abdominal x-ray confirmed malpositioned device with twisted and broken wires, consistent with twiddler¿s syndrome.Revisional surgery revealed twisted and broken leads, that were replaced.The device was secured with an additional transfascial suture over the middle of the device body, assuring satisfactory device immobilization.At the initial post-operative visit the device was functioning appropriately with significant symptom improvement.A (b)(6) year-old obese woman with refractory diabetic gastroparesis four months after revisional surgery the patient reported again recurrence of gastroparesis symptoms, shocking sensation and device mobility.Abdominal radiograph confirmed displacement of the device and twisting of wires, consistent with recurrent twiddler¿s syndrome.On physical examination the device could be easily manipulated and flipped in the pocket.The patient underwent repeat surgical revision.Tyrx antibiotic impregnated mesh envelop (medtronic, minneapolis, nm, usa), was selected for additional device anchoring.Open surgical exploration revealed entwined but intact leads with normal impedance values.The device was found to be loose and freely rotating in a large patulous pocket without any adhesions.The leads were untwined and assured intact.After electrosurgical ablation of the pocket lining, the device was fitted with the envelope and secured with the two standard transfascial prolene sutures.Two additional transfascial perpendicular horizontal mattress-type running prolene sutures, incorporating the tyrx envelope, were used to firmly secure the device to the underlying fascia.The patient tolerated the procedure well with resolution of her symptoms.At three months postoperatively there was no evidence of device mobility with stable position of the device on imaging.Patient remains asymptomatic at the time of publication with 9 months follow up.No specific device information provided.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• 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: 11938705
• MDR Text Key: 265870636
• Report Number: 2182207-2021-00969
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 05/12/2021
• 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
• Patient Age: 53 YR