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

Model Number 3023

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Swelling (2091); Therapeutic Effects, Unexpected (2099); Injury (2348)

Event Date 11/29/2005

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 an implantable neuro stimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor patient reported that suddenly shortly after the implanted they stated having issues with their skin and the implant was causing all this issue as their legs were swelling and they had to be seen by a wound doctor and was wrapped in compression and they also had sores and itching.Patient further explained that the sore started happening to their arms and stomach.Patient also stated that they were allergic to metal and that they had an infection and the device was removed and once it was removed, her body began to calm down although they still have skin issues yet today.Patent also reported that at some put, the stimulation stopped working for them and they never went back to have the system reprogrammed and just stopped using the therapy.Patient stated that they still has to see a wound care dr 1x every 9 weeks.No further complications were noted or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient in response to an inquiry for more details regarding the event: patient weight at time of event was (b)(6), the device was discarded.When asked the circumstances that led to the stimulation stopped working, the patient replied they were never informed to follow up annually.5 years later device was dead.No further complications were noted or anticipated.

• Brand Name: INTERSTIM
• 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: 9370068
• MDR Text Key: 167853257
• Report Number: 3004209178-2019-22527
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

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: 03/28/2007
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 01/03/2020
• Date Device Manufactured: 09/29/2005
• 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: 53 YR
• Patient Weight: 100