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

Model Number	3023
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation or Postural Difficulties (2544); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2008
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3093-28, lot#: j0235480v, implanted: (b)(6) 2003, product type: lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient with an implantable neurostimulator (ins).It was reported that the patient had the device but it did not work that good.The problem came when they wanted it out.It had grown to the nerves and they could not take it completely out.Now it caused pain in that hip and down the leg.They stated when it goes off it was pain that stops them from walking.Additional information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that the ins never worked so they had the device removed in (b)(6) or (b)(6) of 2013.It was stated that a healthcare provider was removing their kidney, because of bladder infections, and the patient told them to remove the implant as well.It was reported that ¿it broke off¿ and was attached to the nerve, and the healthcare provider could not get the rest out.It was stated that the patient periodically gets pain so bad that they holler because of the abandoned portion; it is ¿so bad, shooting through there.¿ no further patient complications are anticipated or expected as a result of this event.
Additional Manufacturer Narrative
Product id 3093-28, lot# j0235480v, implanted: (b)(6) 2003.Product type lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the healthcare professional (hcp).It was reported that the device was explanted on (b)(6) 2013.No cause was provided.The patient stated the device was not working and requested it to be removed at the same time as kidney surgery.During removal, it was noted that the tined lead was intact.No patient complications were reported as a result of this event.

• Brand Name: INTERSTIM
• Common Device Name: 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
• MDR Report Key: 9622028
• Report Number: 3004209178-2020-01647
• Device Sequence Number: 2475339
• Product Code: EZW
• UDI-Device Identifier: 00613994287731
• UDI-Public: 00613994287731
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2009
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 67