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

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found the setscrew was backed out too far.

Manufacturer Narrative

Concomitant medical products: product id: 3037, serial# (b)(4), product type: programmer, patient.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3093-28, lot# va0q7sr, implanted: (b)(6) 2015, product type: lead.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The manufacturer's representative reported that during the procedure impedence showed ??? and >4000 on c and through c and 3.They ran impendence when ipg (implantable pulse generator) was hooked up to the lead and had above impedence issues.They unscrewed battery from lead and cleaned off lead and re-inserted the lead and still had impedence issues.They repeated and physician sewed up incision to make sure the battery was grounded.They still had issues.They then replaced with new ipg and impedence cleared.The issue was resolved at the time of the reporting.The patient status at the time of the reporting was alive - no injury.Indications for use was noted as urinary dysfunction/sacral nerve stim gastrointestinal/ pelvic floor.

Manufacturer Narrative

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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5026511
• MDR Text Key: 24713521
• Report Number: 3004209178-2015-16627
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Supplement Dates Manufacturer Received: 08/25/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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 Age: 00051 YR