MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37602 |
Device Problems
Premature Discharge of Battery (1057); No Device Output (1435); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Impedance Problem (2950)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A healthcare professional via a manufacturing representative reported a patient whose indication for use is dystonia with bilateral globus pallidus intermediate (gpi) deep brain stimulators presented on (b)(6) 2016 with the right battery reading at end of service (eos) just 2 months after replacement.The battery voltage measurement read 2.94 but also showed eos and the battery could not be turned on.The generator appeared to be off but therapy impedance showed a high current reading.The patient did not report worsening of left sided dystonia.Some impedance were low but none were lower than 369.Therapy impedance was 93 which potentially indicated a short circuit.When the battery was interrogated a message was seen stating the delivered amplitude may be lower than the selected amplitude for one or more programs.The right device b setting was 0-2+, 5.0v, 90 usec, and 185 hz and a setting was 0-2+, 3.8v, 100 usec and 185 hz.Impedance values were c/0-369, c/1-642, c/2-808, c/3-731, 0/1-571, 0/2-556, 0/3-777, 1/2-914, 1/3-1010, 2/3-1022.X-rays from (b)(6) 2016 were reviewed and no evidence of lead fracture was found, however both of the lead connectors were overlying the mastoid making them more susceptible to fracture.There was likely a short circuit somewhere due to eos after 2 months and therapy impedance reading low, so they discussed typical plan for replacement of implantable neurostimulator and extension and potential for another surgery to replace the lead if that did not work.
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Manufacturer Narrative
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Information references the main component of the system, other applicable components are: product id: 3389s-40, lot# v167785, implanted: (b)(6) 2008, product type: lead.Product id: 3389s-40, lot# v158028, implanted: (b)(6) 2008, product type: lead.
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Event Description
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Additional information was received from a manufacturer representative (rep).It was reported that the patient was scheduled for a right lead replacement on (b)(6).No other information was received.
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Event Description
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Additional information received from a manufacturing representative reported the implantable neurostimulator (ins) reached end of service (eos) and there was an allegation/dissatisfaction with the ins longevity.The ins was programmed to 0-, 2+ at 5v, 185 usec, and 90 hz.No shorts were noted, but impedances electrode pairings with electrode zero were lower.The patient's health care provider (hcp) planned to test the impedances of the lead first.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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