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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97712
Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Patient Device Interaction Problem (4001)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 03/14/2017
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider, foreign, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient felt overstimulated when she was sitting or lying down. Lead migration was discovered upon examination on (b)(6) 2017. Fixation of the lead to the osseous plane of the sacrum was done on (b)(6) 2017 and the issue resolved without sequelae. The event resulted in an unscheduled clinic or office visit. The etiology was unlikely related to the device or therapy, and not related to the implant procedure. The device diagnosis was lead migration/dislodgement. It was noted that the patient was (b)(6) years old at consent and weighed (b)(6) kilograms.
 
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Brand NameSURESCAN
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 Key11837906
MDR Text Key264361387
Report Number3004209178-2021-07829
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2017
Device Model Number97712
Device Catalogue Number97712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/17/2021 Patient Sequence Number: 1
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