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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427V
Device Problems High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Unable to Obtain Readings (1516)
Patient Problem Undesired Nerve Stimulation (1980)
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical product: product id: 7427v, serial#: (b)(4), implanted: (b)(6) 2002, product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from the patient via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for peripheral neuropathy and arachnoiditis. It was reported that the patient felt stimulation, but it was not in the right location. The rep had stated that they turned the batteries on today to read them and one showed pairs using contact 3 were greater than 4,000 ohms and 4 and 5 showed ¿???¿. The other battery showed all pairs were greater than 4,000 ohms. Technical services reviewed that the battery should be running for about 15 before measurements were taken. Technical services suggested increasing the voltage they were run at and reviewed how to adjust it. The caller indicated that they would try this and call back if needed. The caller also inquired which extensions would be needed if they replaced the inss with the new rechargeable model. It was unknown when the event occurred but the rep stated they thought it was a couple of weeks ago but they weren't sure. The rep called back later the same day for further assistance with impedances and programming. The rep reported that they ran impedances at 3 volts and 210pw, 30hz resulted in 0 and 1 being at 758 ohms, 0 and 3 being at 765 ohms and 1 and 3 being at 765 ohms, but all other combinations were greater than 4,000 ohms. Technical services then asked the rep to run the set higher and they managed to increase to 3. 1 volts with a pulse width of 450pw and 30hz. The results were as follows: 0 and 1, and 0 and 3 were at 839 ohms and all other combinations were greater than 4 ,000 ohms. The patient was currently programmed with 0- 1+ 2-, 450 pw, 30 hz and their stimulation wasn't allowing enough pain relief. Technical services suggested using 0- 1+ 3-, but the patient was getting too much stimulation in their hand. Technical services then suggested decreasing the pulse width and the rep then lowered it to 210pw, 70 hz, 3. 7 volts and this allowed adequate stimulation for the patient¿s arm and shoulder. Technical services also suggested trying 0-1+ and this resulted in similar pain relief at 2. 85 volts, 210 pw and 70 hz. The rep was going to let the patient try the last programmed settings. No further complications were reported/anticipated. See related regulatory report # 3007566237-2019-01746.

 
Manufacturer Narrative

Product id 7427v, serial# (b)(4), implanted: (b)(6) 2002, product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information was received from a manufacturer representative (rep) reporting the impedance issue was due to the ins needing to be turned on for up to 15 minutes before the impedance would read correctly. After 15 minutes the numbers were in range. It was indicated that no further actions were necessary to resolve the impedance issues and the stimulation being in the wrong location. It was indicated that the stimulation issues were resolved. The patient weighed 145 pounds at the time of the event. It was indicated that the provided information had been confirmed with the physician. No further complications were reported/anticipated.

 
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Brand NameSYNERGY VERSITREL
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key8885878
MDR Text Key154143431
Report Number3004209178-2019-15468
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2006
Device MODEL Number7427V
Device Catalogue Number7427V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/10/2004
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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