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

Model Number 3058

Device Problem Unstable (1667)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Tingling (2171)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products:: product id: 3889-28, lot# :0215658206, implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported through a manufacturer representative that she had experienced sharp pain radiating down her right leg.When asked whether she only experienced the pain on her right side, the patient indicated that she also felt paresthesia down both legs while lying on her back.The patient experienced sharp, painful stimulation after a revision procedure that was performed to suture the ins in the pocket after it was found to be flipping in the pocket.Interrogation of the patient¿s system found the device was off at the time of report.As the patient¿s program was set at 1.3 v, an impedance check was attempted at 1 v; however, the patient ¿jumped at the first electrode combination tested,¿ so the remaining test was aborted.An impedance test was later performed while the patient was anesthetized and found that all electrode impedances were within the normal range.The total estimated battery longevity was noted to be 91.2 months.The system was removed at the time of report and the issue was resolved.The patient¿s medical history included chronic pain and it was noted by both the surgeon and anesthetist that it was difficult to obtain a clear history from the patient due to mental and emotional challenges.The patient reported that she had received ¿x8 doses of botox,¿ developed urinary retention, and ended up with a supra-pubic catheter.The patient noted that she ¿had a small bladder capacity of about 50 ml¿ and that her implantable neurostimulator (ins) system was implanted to address her urinary retention.There were no further complications reported or anticipated.

Manufacturer Narrative

H3: 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.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #3 conductor was broken at the distal end of the lead.Continuation of d11: product id 3889-28 lot# 0215658206 implanted: (b)(6) 2018 explanted: (b)(6) 2020 product type lead.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
• MDR Report Key: 10270126
• MDR Text Key: 198758889
• Report Number: 3004209178-2020-12117
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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 Expiration Date: 10/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention