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)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 07/12/2015

Event Type  Injury  

Event Description

It was reported the patient experienced a return of rigidity symptoms after falling down.Impedance testing was performed and found ¿high impedances on his right brain.¿ the patient¿s physician decided to replace their lead as a result of the event.Upon connecting a replacement lead with the patient¿s original extension, the physician experienced a ¿problem when he tightened the screw; he found that two electrodes were broken.¿ the physician then stopped and removed the replacement lead.The patient¿s physician ¿planned to revise the case again¿ the month after initial report.There was ¿no¿ patient injury or death from the event.The patient was being treated with medication at the time of report and was awaiting recovery to undergo an additional revision procedure.Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, explanted: (b)(6) 2015, product type: lead.Product id: 3389-40, lot# 0209659132, implanted: (b)(6) 2015, explanted: (b)(6)2015, product type: lead.(b)(4).(b)(6).

• 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: 4964692
• MDR Text Key: 17851253
• Report Number: 3007566237-2015-02180
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• 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
• Date Manufacturer Received: 07/13/2015
• 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