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

Model Number 3058

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Or Device Fragments Location Unknown (2590)

Patient Problems Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Complaint, Ill-Defined (2331); Electric Shock (2554); Intraoperative Pain (2662)

Event Date 08/24/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim.It was reported that the patient had a problem with the device that if they turned it up enough to do what it was supposed to do it caused a problem with their foot where they would get shocked in their foot and their toes would curl up.It was noted that it had occurred from the beginning.The patient stated they had worked with manufacturer¿s representatives (rep) numerous times, but they were never able to get it fixed so the therapy had never really worked for them.The patient noted that the odd thing was that the trial worked great for them.The patient reported they would play around with their programmer for hours trying to make adjustments, but it didn¿t help and they ended up giving up on the therapy a ¿few months or so¿ after getting the device.It was reported that the patient started to think that getting the device was a bad idea and the implant surgery was kind of a painful one.The patient stated they were disappointed that the therapy didn¿t work for them and they still had the same problem.The patient clarified that it was not like bladder leaking, but a problem where they couldn¿t go pee and they would get infections because of that.The patient noted they did not know the specific dates of the infections.The patient was redirected to their healthcare provider for possible reprogramming.The patient stated they thought they would try to have their healthcare provider invite a rep in.No further complications were reported.

• 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: 7137550
• MDR Text Key: 95465639
• Report Number: 3004209178-2017-26422
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2017

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: 11/14/2010
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 12/21/2017
• Date Device Manufactured: 05/18/2009
• 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): Other
• Patient Age: 53 YR