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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problems Unable to Obtain Readings (1516); Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2019
Event Type  Malfunction  
Manufacturer Narrative

Correction: this regulatory report is a correction report of regulatory report #3007566237-2019-00820. The issue occurred on this device, and there was no issue with the device listed in regulatory report # 3007566237-2019-00820. All future regulatory reports will follow up under this regulatory report submission. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative (rep) and confirmed by the physician regarding a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome. It was reported that on (b)(6) 2019, the rep went to an ins replacement (no device issue was reported) and in pre-op they tested impedances on the new ins with the following programming: -0 3+, -4 7+, 210 us, 30 hz. It was noted the patient's programming was only using contacts 0, 3, 4 and 7. The impedance readings were the following: 0,1 ???; 0,2 1442; 0,3 1442; 0,4 1442; 0,5 ???; 0,6 1442; 0,7 1442; 1,2 714; 1,3 1442; 1,4 1442; 1,5 714; 1,6 1442; 1,7 1442; 2,3 ???; 2,4 ???; 2,5 714. It was noted the impedances also had "<(><<)>15" after them. No symptoms were reported. The rep confirmed they would not be using contacts that appeared with "???" in the impedance reading, so they were not concerned about that, and explained the patient would be using the same program. Technical services explained that the ??? appeared due to a software issue, and that the impedances used in the patient's programming were within normal range. It was also suggested the rep check impedances again after increasing pulse width and then to test at 3 volts or 4 volts. After increasing pulse width and increasing the voltage to 3v or 4v, the impedances still did not resolve, however it was confirmed that the patient was receiving effective therapy. No further complications were reported or anticipated.

 
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Brand NameSYNERGY
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 Key9245052
MDR Text Key175249136
Report Number3004209178-2019-20535
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2009
Device MODEL Number7427
Device Catalogue Number7427
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/05/2008
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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