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

Model Number NEU_INS_STIMULATOR

Device Problem Break (1069)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 06/05/2020

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_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Product id: neu_ens_stimulator, lot# unknown, product type: external neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ens_stimulator, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Hernández-hernández, d., padilla-fernández, b., navarro-galmés, m.Á., hess-medler, s., castro-romera, m.M., castro-díaz, d.M.Sacral neuromodulation in the management of bladder pain syndrome/interstitial cystitis.Current bladder dysfunction reports.2020.15(2):83-92.Doi: 10.1007/s11884-020-00579-z.Summary: purpose of review in this review, the current literature available about sacral neuromodulation (snm) in the management of bladder pain syndrome/interstitial cystitis (bps/ic) will be addressed.Recent findings snmhas emerged in recent years as a minimally invasive option of management for refractory bps/ic patients that otherwise should undergo reconstructive procedures.Although not approved by the fda for this specific group of patients, the available data show a favourable response in both objective and subjective variables with a long-lasting effect.The implantation rate after the test phase is greater with the insertion of the quadripolar tined lead than with the monopolar percutaneous nerve evaluation.Most complications can be managed with reprogramming.The reintervention rate is still high, although it decreases when excluding surgeries for battery exchange.Summary sacral neuromodulation should be considered in the treatment algorithm of patients with bps/ic, as suggested in international guidelines.It provides symptomatic relief in a significant proportion of patients, being a fully reversible procedure with a very favourable complications¿ profile.Reintervention or explantation risk factors have not been consistently established.Reported events: focusing on snm complications, 41.7% of the patients reported pain or discomfort related to the device, being resolved in most cases by reprogramming stimulation parameters except in 2 cases, which required interstim® explant (both associated with loss of effect).There was a lead rupture during the test phase that required major intervention for extraction.The reintervention rate was 75%(9 of 12 patients), including 7 battery replacements and both aforementioned explants, with an average battery duration of 67.17 months (± 26.38).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: 10830417
• MDR Text Key: 217669052
• Report Number: 2182207-2020-01266
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P970004
• 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: 11/12/2020

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?: 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
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/12/2020
• 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