MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 from a healthcare professional (hcp) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient¿s ins and lead were removed as therapy was unsatisfactory in resolving symptoms; the system was not working as expected for at least a year.The hcp noticed that upon removal, there was a white milky type substance grown around the battery.Patient services reviewed with caller that this is not caused by a leaking battery and but is biologic material that is a body response to the ins.There were no trauma/falls reported that could be related to this issue and no unrelated medical issues.The hcp checked impedances and everything was normal except contact c/0 were showing ????.No further complications were reported or are anticipated.

Manufacturer Narrative

The other applicable components are: product id: 3093-28, lot# v323599, implanted: (b)(6) 2009, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp.It was reported that the cause of the system not working was battery corrosion.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6747804
• MDR Text Key: 81186442
• Report Number: 3004209178-2017-15718
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

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: 02/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 08/23/2017
• Date Device Manufactured: 09/06/2013
• 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