MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Connection Problem (2900)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Date 05/06/2015

Event Type  Injury  

Event Description

Rizzi, m., messina, g., penner, f., d'ammando, a., muratorio, f., franzini, a.Internal pulse generators in deep brain stimulation: rechargeable or not? an economical study.World neurosurgery.2015 may 30.Summary: deep brain stimulation (dbs) is a cost-effective strategy for the treatment of different neurological disorders.Nevertheless dbs procedures are burdened by the high costs of implantation and internal pulse generator (ipg) replacement.Different companies propose the use of rechargeable ipgs (rc-ipgs).The aim of our study is to compare the implantation costs of non-rc ipgs versus the estimated costs of rc-ipgs, in order to evaluate if an economical advantage for the health system could derive, in different categories of patients.One hundred and forty nine patients who underwent surgical procedure of ipg substitution were considered.A hypothetic scenario was realized in which the rechargeable ipgs were implanted instead of non-rc ipgs, at the time of dbs system implantation.Moreover, another scenario was outlined in a perspective period of time, corresponding to the patients' life-expectancy.Costs were calculated and inferential analysis performed.Results a savings of (b)(4), including the cost of complications management, was calculated during follow-up period of 7,9 years.In a comprehensive life-expectancy period of 47 years, a saving of (b)(4) would have been obtained (p <(><<)>0.05).Long-term groups data points out that a relevant savings would be expected from rc-ipgs implantation in the dystonic patients (p<(><<)>0.05), in patients with parkinson's disease (p<(> <<)>0.05) and it is projected to occur also in other categories of patients (p<(><<)>0.05).Rc-ipgs implantation presents different clinical advantages, if compared to non-rc devices.Huge economical resources can be spared with the implantation of rc ipgs, in categories of patients implanted with dbs.Reported event(s): 1.2 patients with deep brain stimulation (dbs) for dystonia experienced complications following a non-rechargeable single channel implantable neurostimulator (ins) replacement.It was noted that these complications were ascribable to the ins substitution (ie erroneous connection of the extension cable to the ins and wound dehiscence with or without demonstrated infection).The source literature included the following device specifics: soletra, kinetra, activa sc and activa pc further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant products: product id neu_ins_stimulator, lot # unknown, product type implantable neurostimulator; product id neu_unknown_lead, lot # unknown, product type lead.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4950075
• MDR Text Key: 17312477
• Report Number: 3007566237-2015-02133
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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: 07/01/2015
• 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: 00013 YR