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

Model Number 3058

Device Problems Unintended Collision (1429); Device Or Device Fragments Location Unknown (2590)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Muscle Weakness (1967); Pain (1994); Burning Sensation (2146); Anxiety (2328); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: lead product id:: 3093-28, serial/lot #: (b)(4), ubd: (b)(6) 2016, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation, urinary retention, and gastrointestinal/pelvic floor.It was reported that the patient had a fall 2 weeks after implant, then one a few weeks later and multiple ones since.It also reported that the patient fell in some mud (because their legs gave out) on new year¿s eve 2 years ago and fractured their hip.The patient stated that they used to catch themselves but now they can't because their legs were really weak from laying around for a year and a half and that their lungs ¿are pretty bad¿ (had seen a lung doctor).It was also reported that, when the patient rode to the beach, they broke out in blisters, was scratching from head to toe, and was in so much pain.The patient was in a panic and called their doctor where they were prescribed pain medication and told to follow up with them.When the patient got back to their resort/hotel the began to have breathing problems, was covered in blisters, and itching so bad that they were ¿drawing blood¿.An ambulance was called and they were taken to the hospital.The patient stated that this went on for over a year.The patient stated that they thought the blisters were related to their nerves because they ¿kinda went dead¿ because the lead aggravated them for so long (although this was not proven by a doctor).The patient also had burning when urinating.It was noted that the ins was removed on sept.8, 2016 but the lead was left in.It was unable to be clarified as to the reason why the device was removed.The patient stated that when they ¿came to after surgery¿ they were sent home but their son then told them that they left the lead implanted.The patient stated that if they knew the lead was left in them, they would not have let them send her home from the hospital.It was further reported it felt like the lead was ¿poking¿ the patient in the butt cheek and in their stomach.They further reported that it felt like they were ¿being stabbed¿ and spent most of their time lying down.The patient could not sit and if they did, most of the time their stomach ¿growls really bad¿,had pain in the abdomen, and it felt it was ¿going to explode¿.The patient had been to the emergency room several times and had tried ¿every physician in the region¿ but had been denied care because they were ¿too serious for them to treat¿ (had been told this by everyone).There were no further complications reported or anticipated.

Manufacturer Narrative

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

• 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: 7332029
• MDR Text Key: 102182338
• Report Number: 3004209178-2018-04877
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

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: 09/28/2014
• 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: 03/09/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/30/2018
• Date Device Manufactured: 04/04/2013
• 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
• Patient Age: 46 YR