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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a user facility via a manufacturer representative (rep) regarding an implantable neurostimulator (ins).It was reported that impedance check was performed and readings were at ??? for impedance 2, 3 and 4.Pulse width and amplitude were increased and the same readings were at ???.The lead was repositioned in the ins but would not stay secure after tightening the set screw.Set screw was loosened, the lead was removed, and then repositioned.Set screw was tightened again and would not secure the lead in place.The ins was replaced and the lead was secured in the new ins and impedances were within normal range.No further complications were reported.

Manufacturer Narrative

Corrected information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device received and analysis will be conducted.Supplemental report will be sent with analysis results.Previously submitted fdd, fdr, fdm, and fdc codes updated for receiving device and to match new formatting.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information.

Event Description

No new information.

Manufacturer Narrative

Analysis of the ipg 3058 interstim ll (serial # (b)(4)) determined that the setscrew on the implantable neurostimu lator (ins) was backed out beyond the point of being able to engage with the connector block.Due to the reported complaint, an impedance test was performed in 0.9% saline solution and good impedances were observed using an n'vision clinician programmer.A lab functional test determined there was good stable output on all electrode pairs, analysis determined there were no issues when pressing on the ins can and analysis determined the telemetry was acceptable investigation summary: prior supplemental sent on 2018-jul-27 should have had evaluation code method 4118 and evaluation code-result 3233.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 7468216
• MDR Text Key: 106726075
• Report Number: 3004209178-2018-09443
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

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: 08/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 07/18/2018; 08/02/2018; 08/08/2018
• Supplement Dates FDA Received: 07/27/2018; 08/10/2018; 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR