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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927); Improper Device Output (2953)

Patient Problems Arthritis (1723); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Distress (2329); Numbness (2415)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was reported that the last implant was placed on the other side of the patient¿s body than their first 2 implants.The manufacturer representative reprogrammed the device and the patient tried calling them 3 times with them never returning their phone calls.Last month there was a new manufacturer representative.The patient was in the er and they could not turn off their implantable neurostimulator (ins).The patient could turn down their settings, but could not get it turned off.Yesterday the patient¿s pain was off the charts so they went to the er and took 2 tramadol 100 mg, thinking it was arthritis.The patient called their urologist and then at 3:30 this morning the patient went back to the er because of the pain in their vagina and numbness in their right leg.The patient got a shooting pain in their vagina and down their right leg ever since the implant.The patient had stabbing pain in their vagina when they had intimate relations and they felt like they were on fire.The patient wanted the ins system out of their body and was very frustrated and they told the nurse that yesterday.The patient was assisted with confirming that their ins was off and was assisted with turning it on and switching from program 4 at 1.8v to program 3 at 1.9v.The patient¿s health care provider (hcp) told them to only use programs 2, 3, and 4 and the patient couldn¿t feel the stimulation.It was noted that the patient had a traumatic brain injury.No outcome or interventions were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.Refer to manufacturer¿s reports #3007566237-2013-03990 <(>&<)> # 3004209178-2014-24756 for the patient¿s infections with their first and second ins systems.

Manufacturer Narrative

Concomitant products: product id 3889-28, lot # va0l8cg, implanted: (b)(6) 2014, product type lead; product id 3037, serial # (b)(4), product type programmer, patient.

• 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: 4376293
• MDR Text Key: 5238415
• Report Number: 3004209178-2014-24763
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2014

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: 12/14/2015
• 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: 12/06/2014
• Initial Date FDA Received: 12/31/2014
• Date Device Manufactured: 06/26/2014
• 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: 00052 YR