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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97712
Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

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.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

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.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7661352
MDR Text Key113399185
Report Number3004209178-2018-14998
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2017
Device MODEL Number97712
Device Catalogue Number97712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/23/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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