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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 97714
Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that the ins was in overdischarge for the third time. The patient stated that she was requesting a referral to have her ins replaced. The patient was admitted to the hospital for unrelated reasons and was unable to recharge the device. Surgical intervention was planned, but it was not yet scheduled. No further complications were reported.
 
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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 Key7573099
MDR Text Key110198967
Report Number3004209178-2018-12683
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2015
Device Model Number97714
Device Catalogue Number97714
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 Received06/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/09/2015
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: 06/06/2018 Patient Sequence Number: 1
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