MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN STYLET; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_STYLET_ACC

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 977d260, serial# (b)(4), product type screening device.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a trial patient.The rep reported that the straight stylet bent during use in the trial.The physician placed the needle, removed the stylet and placed the stylet again and it hit a hard structure and came out with a slight bend, but not a kink.The rep confirmed that the bent stylet was not used.The rep stated she ¿can¿t say she noticed a difference or saw that its been bent or not¿ and that she ¿had never any complaints¿ about this in the past.The item was disposed of.No further complications were reported.

Manufacturer Narrative

Additional information indicated this event has also been reported in mfg report (b)(4).Any additional information regarding the event will be documented in this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative.It was reported that a physician was implanting a trial lead using a straight stylet and then found the stylet to be bent after using it.Additional information was received from the manufacturer's representative.It was clarified that the rep did see that the stylet was slightly bent after the hcp used it.The rep was not sure if it was bent because of the use of it or it was possibly slightly bent already and just packaged/sent that way.Cause is still unsure.Additional information was received from the manufacturer's representative.It was reported that the physician had already entered into the patient's body with one pass of the needle, there was minimal pressure placed on the needle, and surely not enough to bend the stylet.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep who reported that the hcp has experienced multiple cases of stylette looking bent.

• Brand Name: UNKNOWN STYLET
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7781654
• MDR Text Key: 117440385
• Report Number: 3007566237-2018-02418
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• 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: 08/22/2018

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: NEU_STYLET_ACC
• Device Catalogue Number: NEU_STYLET_ACC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 08/14/2018
• Supplement Dates FDA Received: 08/22/2018; 08/22/2018
• 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: 49 YR