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

Model Number	3889-33
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
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
Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the lead would not deploy the tines and therefore it was slipping.A new lead was opened and used for the case.No patient symptoms were reported.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Updated to contributed to serious injury.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a healthcare provider via a manufacturer representative.They were asked if the issue occurred out of the box and they responded out of the box.The lead wouldn't stabilize after implanted.They also reported that the cause of this was the tines were not stiff and would not hold.
Additional Manufacturer Narrative
The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device received, analysis not yet complete.If information is provided in the future, a supplemental report will be issued.

• 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: 8209609
• Report Number: 2649622-2019-00049
• Device Sequence Number: 265147
• Product Code: EZW
• UDI-Device Identifier: 00643169887930
• UDI-Public: 00643169887930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2019

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: 04/06/2022
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA1QDLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 02/15/2019; 03/13/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/18/2019; 02/27/2019; 03/27/2019
• 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: 73 YR