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

Model Number NEU_INS_STIMULATOR

Device Problems High impedance (1291); Malposition of Device (2616)

Patient Problem Ambulation Difficulties (2544)

Event Date 05/20/2015

Event Type  Injury  

Event Description

During stage two, impedance testing was performed once the system was fully connected.Electrode 8 was out of range, high impedances of >40 ,000.The surgeon disconnected the lead/extension and extension/implantable neurostimulator (ins) on the right side, cleaned and dried leads, then reconnected the system.Impedances were re-tested and 8 was still out of range.The surgeon decided not to continue troubleshooting and closed up.It was noted that it was unknown which lead was the right lead, but the issue was only with the right lead.The company representative confirmed that there was no effect on the patient immediately post-op as the system was yet to be programmed.The neurologist was informed and programmed the patient accordingly.The patient was receiving effective therapy the week following implant.It was later reported that the post-op ct showed the leads were implanted on the medial side of the original plan.The patient experienced a new onset of gait freezing with stimulation.The change in gait occurred at the left and right side of implant.The physicians have turned off the stimulation and will revise (leads will be replaced) in (b)(6).Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot# 0209047236, implanted: 2015-(b)(6), product type: lead.Product id: 3387-40, lot# 0209313922, implanted: 2015-(b)(6), product type: lead.(b)(4).

Manufacturer Narrative

Device analysis for lead 0209047236 revealed no significant anomaly.The lead body was cut through, product segmented.Device analysis for lead 0209313922 revealed no significant anomaly.The lead body conductor was short between circuits (overstress/damage).Segment 1: short between the all of the circuits, suspected (overstress damage) at the conductor crushed site.Segment 2: short between the # 0, # 1, and # 2 circuits, suspected (overstress damage) at the conductor crushed site.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported that a healthcare professional (hcp) involved with the event "thought that the (lead) deviation might have been caused by a bent stylet tip.".

Manufacturer Narrative

(b)(4).

• Brand Name: 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4828199
• MDR Text Key: 16887844
• Report Number: 3007566237-2015-01592
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 00063 YR