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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problems Impedance Problem (2950); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 3998, lot# j0427741v, implanted: (b)(6) 2004, product type: lead. The main component of the system. Other relevant device(s) are: product id: 3998, serial/lot #: j0427741v, ubd: 21-may-2008, (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative concerning a patient with an implantable neurostimulator (ins) for spinal pain. It was reported the manufacturer representative (rep) met with the patient to perform a voltage check on her prime cell battery. The patient reported excellent coverage and pain relief in her usual painful areas. Impedance test returned electrodes 4,5,6,7 to be out of range. None of these electrodes were being used in her current and successfully programming. The patient confirmed she was aware of the out of range electrodes and that she was told years ago. The patient also confirmed that the out of range electrodes did not hinder her therapy or pain relief. The patient was unable to confirm the timeframe of the initial out of range electrode. No patient symptoms were reported. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePRIMEADVANCED
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 Key7720244
MDR Text Key115409898
Report Number3004209178-2018-16656
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2015
Device Model Number37702
Device Catalogue Number37702
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 Manufactured03/26/2014
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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