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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516)

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

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id: 3889-28, lot# va10ptq, implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.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.

Event Description

Information was received by a manufacturer representative (rep) from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins).The hcp reported that the patient was having a lead revision due to lead migration.After the lead was replaced the original ins was connected, but impedance checks on the case showed "???" while other combinations were normal.Impedances were checked again at 2.0 and 300 pulse width, then at 3.0 and 300 pulse width, then 4.0 and 300 pulse width, and finally 5.0 and 300 pulse width whoever the issue was not resolved.The hcp connected a new ins and ran impedance tests again and all were normal.The issue was resolved at the time of this report and it was noted that the cause of the lead migration was not known as the patient did not fall or have any trauma to their body.There were no further complication reported or anticipated.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) model 3058 serial (b)(4) showed no significant anomalies and passed final functional testing.Due to the nature of the complaint, an impedance test was performed with a known good placed in 0.9% saline solution and normal impedances were measured using various parameters.Good, stable output was observed on all electrode pairs when received.The telemetry was determined to be acceptable.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device received, analysis not yet complete.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information reported.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6879171
• MDR Text Key: 86747640
• Report Number: 3004209178-2017-19701
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

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: 06/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 11/06/2017
• Supplement Dates FDA Received: 09/27/2017; 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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: 62 YR