MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Peeled/Delaminated (1454); Stretched (1601); Device Operates Differently Than Expected (2913)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system, other applicable components are: product id 3387-28, implanted: (b)(6) 2017, product type lead.

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that the patient was implanted with the deep brain stimulation (dbs) lead on (b)(6) 2017.On (b)(6) 2017 the implantable neurostimulator (ins) was implanted and during the procedure when the right side lead cap was removed, the electrode conductors on the lead were detached from the lead coating; the conductor wires were exposed.It was also noted that procedure was performed as usual when the event occurred and there was no particular forced used to cause the issue.The lead remained in use as the hcp decided that if necessary, a new lead would be positioned.The rep also stated that "beriplast is usually used as adhesive bond to suture dura, however, duraseal blue spray (integra company) was used for the first time in this procedure.The spray might have been applied to the lead coating." to resolve the exposed conductor wires, the lead coating was covered by plastic materials and tightened with thread; the wires were no longer exposed.Follow-up with the health care provider (hcp) indicated that they considered the exposed conductor wires to be coiled initially but were stretched.The wires were covered by a boot for protection and no abnormal impedances were observed; the lead remained in use.It was then stated that per the hcp, "during removing a boot used for the extension after removing the extension rather than during removing the extension for test stimulation, the boot was interfered/entrapped by some factor and it led to split the electrode conductors and its coating; the conductor wires were exposed.Two boots were covered the exposed wires".It was unknown if the event was resolved at the time of this report.There was no known impact or consequence to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

The lead s/n (b)(4) was not returned.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.

Event Description

Additional information was received from a manufacturing representative.It was reported that at the time of the report two boots with the same size were tied with a non-absorbable suture.They needed to confirm whether or not there was an issue with the strength.

Manufacturer Narrative

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

Event Description

Additional information received from a hcp via a rep clarified that the lead was damaged but the cause was undetermined.It was inquired by the hcp if the lead could possibly be kinked and/or damaged while a boot was passed through the lead in order to avoid the same issue.No further complications are anticipated.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 6914049
• MDR Text Key: 88157993
• Report Number: 3007566237-2017-04173
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2017

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: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 11/01/2017; 11/20/2017
• Supplement Dates FDA Received: 10/30/2017; 11/14/2017; 11/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0187-2009
• Patient Sequence Number: 1