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

Model Number	3023
Medical Device Problem Codes	Difficult to Remove (1528); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 3080, lot#: l74010, implanted: (b)(6) 2000, product type: lead.Other relevant device(s) are: product id: 3080, serial/lot #: (b)(4), ubd: 29-nov-2003, udi#: (b)(4).Date of event: date is estimated; month and year are valid.Explant date (2021 reports): (ins explant date): date is estimated; month and year are valid.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that the patient's ins was removed, but they could not get the lead out because the lead was so attached they did not want to do any more work.Their doctor resolved the device.Additional information was received from the patient.They reported that no healthcare provider was currently managing their device.The ins was removed and the lead was attempted to be removed in (b)(6) of 2021.The cause of the lead abandonment/not being able to get the lead out because it was so attached (explant difficulty) was reportedly determined.When asked what most likely caused or contributed to this issue, they responded "unable to detach leads." when asked to clarify the report their doctor had resolved the device and what steps were taken to resolve the issue, they replied the battery was removed and the leads were still attached.The issue was not yet resolved.When asked if additional surgery was planned to remove the lead, they reported there was not a planned date yet.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 12155209
• Report Number: 3004209178-2021-10705
• Device Sequence Number: 3775384
• Product Code: EZW
• UDI-Device Identifier: 00613994287731
• UDI-Public: 00613994287731
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: 01/14/2009
• 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: 06/14/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR