MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3058
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2018 (b)(4) (con): information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient reported seeing poor communication when they went to use their programmer to change settings.The patient programmer (pp) would not do telemetry with or without antenna.It was noted that the patient used an antenna.It was reviewed for patient to confirm antenna was secure and sync with ins but that did not resolve the issue.It was reviewed for patient to unplug the antenna, and place the pp directly over ins, on skin and sync and this did not resolve the issue either.Patient was warm transferred to repair department.No patient symptoms were reported.Patient's medical history included parkinson's disease which was there prior to implant.No further patient complications were reported/ anticipated as a result of this event.On (b)(6) 2018 (b)(4) (con): patient reported the same programmer issues and noted that the pp was replaced.Patient also reported the need to get in contact with the local rep before getting discharged from the hospital the day of the call.It was unknown if the hospitalization was related to the device or not.On (b)(6) 2018 rpl update: no new information reported.
Additional Manufacturer Narrative
The report was previously sent on the wrong device.Correction has been made and the report is now on the correct device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• MDR Report Key: 7371621
• Report Number: 2182208-2018-00340
• Device Sequence Number: 13634214
• Product Code: EZW
• UDI-Device Identifier: 00643169512955
• UDI-Public: 00643169512955
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 03/26/2018
• 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: Hospitalization
• Patient Age: 71 YR