MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems High impedance (1291); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product event summary #event details for 3889-28 model number: not specified serial or lot number: 0221601196 if information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare provider reported that the lead was replaced as the patient had lost symptom control but could still feel stimulation.The patient had apparently tried all programs and could feel stimulation on very low settings (<(><<)>0.4v).Patient had a successful trial earlier.Lead was x rayed in theatre and position looked satisfactory.Surgeon removed lead with no problem.Ipg was found to have a lot of blood in it before lead was disconnected.Surgeon wondered if silicon sleeve on header block was too big and had allowed fluid in.Lead was then disconnected and surgeon replaced lead with no problem.Good responses found with new lead testing.Surgeon tried to remove fluid and blood from header block but wasn't able to do so 100%.Surgeon attached new clean lead to old ipg and placed ipg in pocket.Impedance checks done several times returning >4000ohms on many electrode combinations.Surgeon disconnected lead and reconnected a further 3 times and was unable to obtain satisfactory impedance results.The >4000ohms kept changing between different electrode combinations.Impedance was checked on 1v and increased voltage also and pulse width.Surgeon wondered if the ipg header block silicon sleeve was stretched/too large thus allowing fluid to enter the header block.Surgeon elected to replace the ipg.New lead connected to new ipg satisfactorily and no evidence of fluid in header block.Impedance check on 1v and 1.4v whilst patient still asleep, again varying impedance >4000ohms on differing electrode combinations.Surgeon disconnected lead and cleaned again, and connected again.No visible issue noted with the new lead.Same impedance issue.Surgeon elected to leave the new ipg and new lead connected insitu.Surgeon wondered if problem was perhaps due to internal bleeding at the site and increased resistance.

Manufacturer Narrative

H3: analysis information (b)(6) 2021 10:42:30 cst pli# 10, product id# 3889-28, below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis determined that there was a short between the #1 and #2 conductors in the body of the lead under dry conditions.Analysis information -- 02.11.2021 10:32:26 cst pli# 30 product id# 3058below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing; however foreign material was observed in the implantable neurostimulator (ins) connector port.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12385296
• MDR Text Key: 268717435
• Report Number: 3004209178-2021-13080
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention