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); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that the patient noticed the last day or so but the significant change was the day before reported event date where the patient feels like the lead has shifted because he used to feel the stimulation in his scrotum and anus but now feels it in his buttock cheek.The patient stated he had tried different programs, turning up the stimulation because he was not feeling it at all and when he does feel it, it was not in the right location and the last program was too high so he had not tried that one.He had been going to the gym to work out and maybe he did something there that affected the system.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

Manufacturer Narrative

Concomitant products: product id 3037, serial # (b)(4), product type programmer, patient; product id 3889-28, lot # va0g6fr, implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 4375796
• MDR Text Key: 16543496
• Report Number: 3004209178-2014-24742
• 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: 12/05/2014

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: 03/14/2016
• 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: 12/05/2014
• Initial Date FDA Received: 12/31/2014
• Date Device Manufactured: 09/16/2014
• 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: 00033 YR