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

Model Number 3889-28

Device Problems Unsealed Device Packaging (1444); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device analysis revealed the packaging inner lid was loosened allowing component movement.If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that ¿although the curved stylet was in a sterile packing, it protruded beyond the sterile case inside.¿ after considering the risk that the curved stylet would come into contact with the non-sterile field when the outside nurse opened the packing and handed it over to the nurse who took the product out, the product was not opened.There was no patient injury associated with the event and the cause of the issue was not provided.There were no complications reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9974834
• MDR Text Key: 188197833
• Report Number: 2649622-2020-07822
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1PCFG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1