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); Device Operates Differently Than Expected (2913)

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was being implanted with a neurostimulator.It was reported that the sterile packaging of the lead looked compromised.Although it was not opened, it appeared there was slight water damage on the tyvek component of the packaging.The healthcare professional (hcp) made the decision to use the lead and, once it was deployed in the patient, they tested the electrodes looking for patient sensory and motor response.The 3 and 2 electrodes seemed to work and produced the appropriate responses, but the 1 and 0 electrodes did not garner a response from the patient.A decision was made to open a new lead and the problem was resolved.There were no symptoms or further complications reported or anticipated.

Manufacturer Narrative

Analysis of product id# 3889-28 found no anomaly as the returned device passed all functional testing in the laboratory.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of medical product: product id: neu_stylet_acc, serial# unknown, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6965744
• MDR Text Key: 90248567
• Report Number: 2649622-2017-12801
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

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: 09/15/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1KSM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 10/18/2017; 12/01/2017
• Supplement Dates FDA Received: 11/03/2017; 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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: 81 YR