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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported the essential tremor patient experienced reduced therapy post-operatively with ¿less than 50% therapy relief.¿ the patient also experienced a shocking sensation down their arm and spasms.These issues were reported to have occurred after the patient had a large fall.Prior to the fall it was noted he patient ¿had good tremor suppression.¿ a revision procedure was performed whereby the patient¿s scalp was opened and it was observed the lead was ¿visibly fractured.¿ the lead was ¿fractured slightly distal from where bone cement secured the lead.¿ it was noted the ¿damage was detected capping the lead.¿ impedance testing was performed with an external neurostimulator (ens) at that time and found that contact 0 was ¿open.¿ as a result, the bone cement present with the lead was drilled and the lead was removed and replaced with a new lead.The patient was to have their therapy switched on 17 days aft er initial report.Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id 3387-28, lot# unknown, implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: lead.(b)(4).

• 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 120
• 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: 4841423
• MDR Text Key: 5910486
• Report Number: 3007566237-2015-01640
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• 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 Weight: 90