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

Model Number 3889-28

Device Problems Unsealed Device Packaging (1444); Shipping Damage or Problem (1570)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The main component of the system and other applicable components are: product id: 3058, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.

Event Description

Information was received by a manufacture representative (rep) via an hcp regarding an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.Hcp reported a lead sticking out from the plastic packaging under the peel strip.No troubleshooting was involved and another lead was opened and implanted into the patient.Additionally, the sterility of the lead was questioned.No patient symptoms reported.

Manufacturer Narrative

No device analysis was performed; the lead was returned in the plastic tray only and not in the sterile packaging.The packaging complaint was unable to be verified.

Manufacturer Narrative

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

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
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6312604
• MDR Text Key: 66861716
• Report Number: 2649622-2017-00089
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2017

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: 09/23/2020
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1AXEF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided; 04/06/2017; 04/06/2017
• Supplement Dates FDA Received: 04/10/2017; 09/29/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR