MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3889-28
Medical Device Problem Codes	Failure to Deliver Energy (1211); Unintended Collision (1429)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system and other applicable components are product id: 3058, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative via a consumer regarding a patient who was implanted with a neurostimulator.It was reported that patient stated they fell and experienced a loss of efficacy.Patient claimed they had tried different programs and could not feel stimulation, and that reprogramming was done by the physician's office.The lead is planned to be replaced.No further complications were reported.
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 3058, serial (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that the device was discarded.There were no symptoms or further complications reported or anticipated.
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 3058, serial (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that the cause of the patient fall and not feeling stimulation was not determined.There were no symptoms or further complications reported or anticipated.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7280261
• Report Number: 2649622-2018-02657
• Device Sequence Number: 16458979
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2018

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: 06/13/2020
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA17P3L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/19/2018; 02/23/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 02/23/2018; 02/28/2018
• 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: Required Intervention
• Patient Age: 85 YR