MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3531

Device Problems Bent (1059); Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889, lot#: va1gwge, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.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 lead for urinary dysfunction/sacral nerve stim, bowel dysfunction/sacral nerve stim, and gastrointestinal/pelvic floor.It was reported the patient was in advanced trial today and the lead was being placed with a bent stylet in.The tines were not deployed.They got 3/4 contacts to respond.The doctors tried to pull the stylet out of reposition and the lead shredded.Contacts 0 and 1 were farther away than contacts 2 and 3.This was confirmed by x-ray.The doctor was able to remove the lead in tact and replace the lead and finish the trial.The caller noted they would return the product.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: the main component of the system and other applicable components are product id: neu_stylet_acc, serial# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received with rep reporting that they did not have access to the patient weight even after checking with physician.Rep further elaborated on description of event; stating that they only got 3/4 contacts to respond the doctor tried to reintroduce the lead.The bent tip stylet was still in place and the "steer-ability" feature of the stylet was being used to obtain 4 out of 4 electrodes with an s3 motor response.The tines had not been deployed at this time and the second white marking on the lead was still visible above the sheath.The doctor attempted to retract the lead from the sheath to use its steer-ability and get 4 out of 4 contact points with motor response.When pulling back the lead from the sheath, the lead malfunctioned and contacts 0 and 1 were farther away than contacts 2 and 3 which was confirmed by x-ray before fully removing the lead from the sheath.The doctor was able to remove the lead fully intact.The lead was no longer used as the electrodes had moved further away from one another and dam age was noted to the lead.A new lead was opened and used.The sheath remained intact and the new lead was reintroduced using the same sheath that was in place for first lead.The new lead was able to get 4 out of 4 electrodes with motor response as desired.It was not determined what caused lead to shred or separate other than the doctor meeting a unusual resistance.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Analysis of the lead (lot # va1gwge) found that the distal end was stretched, the distal end of the lead was bent, and the outer insulation of the lead was broken/torn under electrode #2.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.The returned lead with the returned stylet was inserted into a known good introducer sheath and then the returned lead with the returned stylet was retracted, all with no problems.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERIFY
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6849007
• MDR Text Key: 85147680
• Report Number: 3007566237-2017-03688
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2017

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 Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/11/2017; 10/20/2017
• Supplement Dates FDA Received: 09/21/2017; 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention