Model Number 3660 |
Device Problems
Battery Problem (2885); No Apparent Adverse Event (3189)
|
Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
Injury
|
Manufacturer Narrative
|
Event date is unknown.During processing of this complaint, attempts were made to obtain complete event, patient and device information.
|
|
Event Description
|
It was re[ported that the patient was receiving an elective replacement indicator (eri) message and the ipg was inoperable.External devices were unable to connect to the ipg.As a result, surgical intervention may occur to address the issue.
|
|
Manufacturer Narrative
|
During processing of this complaint, attempts were made to obtain complete patient information.
|
|
Event Description
|
It was reported that the patient's ipg was explanted and replaced on (b)(6) 2021.The patient has effective therapy post operatively.
|
|
Manufacturer Narrative
|
The reported observation of ¿ipg replacement scheduled¿ was confirmed.The root cause of the reported observation was due to the device having normal battery depletion to the end of life (eol).The device provided therapy per the programming up to the eol declaration date at which time therapy is inhibited.The estimated minimum bol longevity range based on the 3 programs used would have been 1.75 years up to 6.5 years.Program#3 was utilized 82% of the implant period with a longevity estimate of 1.75 years +/-.25-year per ¿ (b)(4), assuming 500-ohm lead impedances for device model 3660.
|
|
Search Alerts/Recalls
|