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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problems High impedance; Malposition of device
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).

 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, 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 Key4828199
Report Number3007566237-2015-01592
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2015
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 TREATMENT DATA
Date Received: 06/09/2015 Patient Sequence Number: 1
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