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

Model Number 3058

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: (b)(6) 2014, udi#: (b)(4).(b)(4) apply to product id: 3889-28.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from health care professional (hcp) regarding a patient implanted with a neurostimulator for overactive bladder and urgency.It was reported that the patient had the device for 8 years but she had noticed that the device was not working well and there were impedances present so the entire thing was removed and replaced.The hcp reported that after informed consent was obtained, the patient was taken to the operating room and excellent sedation was induced after she was put into the prone position and all the pressure points were padded.The hcp stated that a ground pad was placed on the bottom of the patient's foot and a long test stimulation cable was connected to the ground pad in the external test stimulator.The hcp noted that the patient was prepped and draped in usual sterile fashion and marcaine and lidocaine with epinephrine were injected into the incision over the generator pocket.It was mentioned that an incision was made there and the generator was removed, the wire was cut and an incision was made over the insertion of the wire as well.The hcp noted that over the tailbone, the hcp attempted to remove that by rolling it and applied a constant pressure, however, the lead had broke so the rest of it was left in situ and the c-arm was then moved into position.There were no further symptoms or complications reported or anticipated.

• 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: 7558086
• MDR Text Key: 109702385
• Report Number: 3004209178-2018-12285
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

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: 08/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 05/31/2018
• Date Device Manufactured: 03/04/2010
• 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