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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Malaise (2359); Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2012

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as follows: ins pain/swelling "a couple of years"; not feeling stimulation increase: (b)(6) 2018.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 fecal incontinence and gastrointestinal/pelvic floor.It was reported that the ins site was hurting the patient and was swollen (¿as big as the palm of her hand¿).On friday, the patient got a ¿real sharp pain¿.They noted that it had been uncomfortable for a couple of years but they would push it down a little bit and it would go away.However, it had gradually gotten worse.It was also reported the patient used the programmer to increase the stimulation all the way to 8.5 and did not feel any increase in the fluttering feeling (stimulation sensation).The patient stated that, since implant, they had noticed an improvement in their symptoms and had changed their diet.There were no further complications reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 3093-28, lot#: v828528, implanted: (b)(6) 2012, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient thought she had a fall and pocket site was sore.The patient¿s implantable neurostimulator (ins) was explanted and replaced.The original lead was left in because it had encapsulated and was going to break.The hcp went into the pocket of original battery site (left side) and discovered a sponge that was left in during the 2012 procedure.There was no sign of infection and the patient had another infectious disease the doctor took a look at it.The pocket was cleaned out, the sponge was removed, and the pocket was closed.It was noted that x-rays were taken to show that all the sponge was removed.The hcp determined it was ok to place another lead and battery on the opposite side.The patient did well post operation and the new lead and battery are working well.The patient was sent home with antibiotics.The battery and sponge were sent to pathology per hospital protocol.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Follow up information received from the patient reported that they did notify their doctor for the issue.The patient noted that the circumstances that led to the issue were, in (b)(6), they started to feel pain and swelling in the area where the device was inserted.They mentioned they were sick for a month and did try the device later on but did not feel any ¿flutter¿ even when going higher up to 8.5.The patient stated the cause was determined that, when they saw the physician in (b)(6), they ¿measured the device¿ nothing was working.As a step to resolve the issue, the patient was operated on to remove the device as it had moved and was pushing against their skin (which was the reason for them hurting).They reported that the issue was resolved after the device was removed and a new one implanted on their right side.Further follow up information received from the manufacturer¿s representative reported that the doctor felt cause of the lead being encapsulated was from the sponge.Also, another physician (an infectious disease doctor) was call in to see the sponge and they felt it was ¿ok¿ to continue the case and place the battery on the patient¿s opposite side.The doctor decided to leave the lead because it would break.

• 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: 7352309
• MDR Text Key: 103086626
• Report Number: 3004209178-2018-05328
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

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: 03/28/2013
• 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: 03/19/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/02/2018; 04/03/2018
• Supplement Dates FDA Received: 04/04/2018; 04/05/2018
• Date Device Manufactured: 10/04/2011
• 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: 72 YR
• Patient Weight: 64