Device 4 of 5.Reference mfr.Report#: 1627487-2018-00955, reference mfr.Report#: 1627487-2018-00957, reference mfr.Report#: 3006705815-2018-00211, reference mfr.Report#: 1627487-2018-03316.It was reported the patient stated while reaching for something on (b)(6) 2017, she heard a "pop" in her shoulder.The next day, the patient had lost stimulation.As such, a company representative met with the patient for reprogramming which initially resolved the issue.However, the issue reoccurred.Diagnostic testing revealed high impedance values on multiple lead contacts.Imaging revealed the extensions had pulled out of the port 1-8 and all lead contacts have high impedance values.As a result, the patient underwent surgical intervention on (b)(6) 2018 where the ipg was explanted and replaced.In addition, one extension was explanted and 3 were implanted.Please note, it is unknown which extension was explanted and replaced.Therefore, all suspected devices are being reported.Please note: two model 3383 extensions have been added to this report as ( devices 4 and 5).The analysis of the extensions revealed the device tested out of specification in a manner that relates to the reported event.
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