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

Model Number NEU_UNKNOWN_LEAD

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

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

Event Type  Injury  

Event Description

It was reported that over the last six months the healthcare provider (hcp) had noticed increased difficulty with the stimloc holding the lead in place.The lead seemed to slip through more easily and the hcp had to replace the migrated lead.The hcp had not had to do this in the eight years prior to this time.The hcp spoke with a manufacturer representative (rep) and was given some ¿pointers¿ on how to use the stimloc better.The hcp changed her practice to use these ¿tricks¿ and began using fluoroscopy after burying the lead, which she had not done in the past.The cause of the leads migrating and more details about the issue were not reported, so additional information was requested.If additional information is received a supplemental report will be sent.Refer to manufacturing report #3007566237-2015-01933 as the hcp had two cases of lead migration over the six months.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that there were no patient symptoms involved with this event.It was noted that a lead replacement was performed.

• Brand Name: UNKNOWN LEAD
• 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: 4906484
• MDR Text Key: 6070925
• Report Number: 3007566237-2015-01934
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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