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

Model Number	3889-33
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Receipt by User (1570); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
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 healthcare provider (hcp) via a manufacturer¿s representative (rep) regarding a trial patient using an external neurostimulator (ens).It was reported that during implant the surgeon was attempting to place the lead and having trouble.The hcp noticed the lead was punctured right above the electrodes and they had to use a different lead.The rep reported the issue was occurring out of the box.No patient symptoms were reported.No further complications were reported.Additional information was received on 2019-jun-25 from a healthcare provider (hcp) via a manufacturer¿s representative (rep) indicating that the issue occurred during an advanced evaluation procedure.No further complications were reported.
Additional Manufacturer Narrative
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 (hcp) via a manufacturer¿s representative (rep) indicating that the hcp inserted the lead into the introducer sheath and noticed the lead was defective.The stimulation provided no motor response, sot the defective lead was replaced.No further complications were reported.
Additional Manufacturer Narrative
Analysis of the lead lot number va1zj1b found the stylet wire has perforated the conductor coils near the distal end of the lead.The outer insulation is separated at the butt joint.The #3 electrode is scratched.Procedural non-conformance.Analysis identified that the stylet coil was perforated by the stylet (x) cm from the distal end.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: 8772568
• Report Number: 2649622-2019-11826
• Device Sequence Number: 16538569
• Product Code: EZW
• UDI-Device Identifier: 00643169864443
• UDI-Public: 00643169864443
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2019

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: 04/30/2023
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA1ZJ1B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 10/16/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/15/2019; 10/17/2019
• 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 Weight: 50