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

Model Number 3058

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem Numbness (2415)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: the main device component of the system and other applicable components are: product id: 3889-28, lot# j0454671v, implanted: (b)(6) 2004, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported the patient had their device taken out on (b)(6) 2017.The patient stated he had his battery taken out so he could have an mri.The patient stated he didn¿t have everything taken out and that the tined was broken off.They also stated that their device quit working.Patient also experienced numbness in hips and down their legs.The patient stated the hcp stated it would be ok to have an mri done.The patient the ¿box¿ was taken out.The patient could not clarify was taken out.The patient stated the hcp stated the only way something could be taken could be removed would be a major surgery.There were no further complications that have been reported as a result of this event.**information omitted about 2003 implant as it is covered in (b)(4).

• 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: 7038333
• MDR Text Key: 93346504
• Report Number: 3004209178-2017-23893
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2017

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: 05/28/2014
• 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: 11/13/2017
• Initial Date FDA Received: 11/16/2017
• Date Device Manufactured: 11/30/2012
• 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: 61 YR