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

Model Number NEU_INS_STIMULATOR

Device Problems High impedance (1291); Difficult to Insert (1316); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/23/2015

Event Type  Injury  

Event Description

The patient experienced a return of symptoms.On a normal clinic visit the patient was investigated to see what may be the cause of the symptom return, and it was noted that the impedances were high of greater than 10,000ohms with c<(>&<)>8, c<(>&<)>9, c<(>&<)>11, 8<(>&<)>9, 8<(>&<)>10, 8<(>&<)>11, 9<(>&<)>10, and 9<(>&<)>11.Impedance testing was performed.The decision was taken to investigate inter-operatively.The lead was disconnected from the extension first and tested using an external neurostimulator (ens), impedances were still showing out of range.It was very difficult to get the stylet passed the proximal contact.It was agreed that the lead was the problem thus it was explanted and a new lead implanted.When tested, it had normal range impedances.The issue was resolved.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 3389-28, explanted: (b)(6) 2015, product type: lead.(b)(4).

Manufacturer Narrative

Correction: please note that conclusion and result no longer apply to this report.Device evaluation: analysis of the lead found that ¿all conductors were broken at their respective weld sites at the proximal end.¿.

Manufacturer Narrative

Conclusion was updated.

• 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: 4915810
• MDR Text Key: 16561073
• Report Number: 3007566237-2015-01974
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/15/2015
• 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