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

Model Number	3058
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Collision (1429); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient via a company representative (rep).It was reported that patient followed up in office and reporting that system was not working.There were abnormal impedances noted during interrogation by office staff.They were unable to obtain battery life status during interrogation.Patient reported that she had fallen a couple times and fell on unit.The device had not worked well since.The implantable nuerostimulator (ins) battery was also very loose in the pocket.The full system replacement occurred on (b)(6) 2017.The issue was resolved at time of the report.Patient status was noted as alive, no injury.The indications for use for this patient were urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.
Additional Manufacturer Narrative
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 00777
• MDR Report Key: 6266232
• Report Number: 3004209178-2017-01339
• Device Sequence Number: 18930925
• Product Code: EZW
• UDI-Device Identifier: 00613994601957
• UDI-Public: 00613994601957
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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: 08/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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