MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97712 |
Device Problems
Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Type
malfunction
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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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Event Description
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Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported the patient¿s device was off/disabled and no longer providing therapy.Patient was getting an error message whenever she tried to use her recharge system.Patient confirmed error message she got was end of service (eos) and 589, and eos was on the same screen as the 589.Patient stated this happened with only one of her implant batteries and the other battery recharged fine.Patient services (pss) reviewed meaning of eos and consulted with stim tech, reviewed that 589 mean the battery voltage was too high (usually happened when they repeat try to charge ins after it had already been fully charged).It was noted her battery was replaced before.Patient contacted to representative (rep) and rep told him that it was impossible to need a new battery because patient recently had her batteries replaced.It was mentioned patient used her old recharger for her new system, and that was why she had problems because rep thought the recharger patient had did not go with patient¿s implant.Patient stated she had problems with recharger, she mean not being able to charger one of her implant.Patient stated her patient programmer (pp) showed that her implant battery that she was unable to charge, and needed to be recharged, it was 1%.Patient had no problem with pp, it only showed that she needed to recharge, and she had problem with recharge when she tried to charge.Patient connected with pp, her pp showed her implant battery level of 1%, her battery was dying and needed to be charge.Patient stated pp worked fine and just showed that she needed to recharge, but when she went to recharge then she got the errors.Patient tried to connect with recharger and confirmed recharger showed the reposition antenna screen.It was noted the patient got eos and 589, 1% on pp implant was dying, and needed to be charged/cannot recharge one of implant and reposition antenna.It was noted the recharger kept getting reposition antenna and wouldn¿t charge unit.There was an allegation/dissatisfaction with ins longevity, and patient recently had batteries replaced.No further complication and no symptoms were reported.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from patient.Patient stated it was unknown, and maybe new batteries for the circumstance that led to patient got end of services (eos), and 589, not being able to charge implant, and 1% on patient programmer that implant was dying.Patient noticed the replacement of the rechargers resolved those issues above, patient had no problems thus far.No further complication and no symptoms were reported.
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Search Alerts/Recalls
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