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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885)
Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: m943899a, serial#: unknown, product type: accessory. Product id: 97745, product type: programmer, patient. Product id: 977a260, serial#: (b)(4), product type: lead. Product id: 977a260, serial#: (b)(4), product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 19-nov-2023, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 19-nov-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins). It was reported that the patient mentioned belt product enhancement suggestions. See (b)(4) for longer charging times and controller/ recharger telemetry module (rtm) replacement. It was also reported that the patient had left anterior chest wall stimulation. The patient reported unresponsive screens on the controller and also seeing "system problem rm06" message last saturday. Since then, the patient has been at zero and no therapy delivered. It was reported that the circumstances that led to the chest wall stimulation was due to turning it on after implant at 1st post-op visit. Patient reported lead dislodged stopped chest wall stimulation. Patient stated they got a new donut programmer and battery pack for controller sent. Patient stated the issue resolve due to lead moving on its own. Patient stated they can't get device to fully charge to finish.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12288536
MDR Text Key265419190
Report Number3004209178-2021-12027
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
Report Date 08/06/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/14/2021
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/15/2020
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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