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

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.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, 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 Key: 9245052
• MDR Text Key: 175249136
• Report Number: 3004209178-2019-20535
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2009
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Date Device Manufactured: 05/05/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR