MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
|
Back to Search Results |
|
Model Number NEU_INS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Skin Erosion (2075); Therapeutic Effects, Unexpected (2099)
|
Event Date 07/23/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant product: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.(b)(4).
|
|
Event Description
|
The health care provider (hcp) reported via the company representative (rep) that on (b)(6) 2015 the lead, implanted in the occipital right, was removed in emergency after "the externalization of the electrode under the skin." in absence of the electrode, the pain felt by the patient was not correctly/properly relieved.The issue was resolved at the time of the report.If additional information is received, a follow up report will be sent.
|
|
Manufacturer Narrative
|
Device analysis for lead (b)(4) revealed no significant anomaly.The lead body was cut through, product segmented.The lead was cut 77.5cm from proximal end.
|
|
Search Alerts/Recalls
|
|
|