MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97702

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was implanted for lumbar radiculopathy.It was reported via a manufacturer representative that the non-rechargeable implantable neurostimulator (ins) had been placed 2 days prior to the report on (b)(6) 2016.Elective replacement indicator was seen on (b)(6) 2016.It was reported that the device was still on and providing therapy.The settings were 450 pw, a rate of 100, and a ¿higher¿ amplitude.The caller noted that they remembered seeing a lower impedance on a contact but they did not remember if that contact was used in programming.This information indicated that a short circuit was used in programming.Additional information from a manufacturer representative reported that the settings of 6.4v, 450 microseconds, 100hz, and contacts 1,2,3,4 were being used.The ins had been turned off since the eri was seen.Group impedances at these settings were attempted but ¿xxx¿ was seen for both ohms and ma.The manufacturer representative lowered the voltage to 3v and got a group impedance reading of 35ma.Electrode impedances were run and found that 0 and 3 had 10,000 ohms.The current battery level showed 3.130v.The manufacturer representative changed the programmed to just have 1 and 2 when they ran the group impedances it showed 1039 ohms and 2.922ma.The manufacturer representative was unsure if the impedances were checked at the time of the ins replacement.The patient had not had a fall or trauma since the replacement on (b)(6) 2016.Additional information from another manufacturer representative clarified that the impedances were fine post implant.The patient had been programmed at 8.2v, 450 pw, 60hz with 0-,1-, 2+, and 5+.The therapy impedance were 380 ohms and 20.553 ma.The estimated longevity was 4 months.All contact with contact 4 was showing <(><<)>50ohms.This manufacturer representative reported that when they met the patient the voltage was at 0v and the patient was programmed with electrode 4 with 1+,2-,4-, and 5+.Electrode impedance was re-tested with the following results: reference 0 with 1: 803 ohms, with 2: 797 ohms, with 3: 10k ohms, with 5: 746 ohms, with 6: 821 ohms, and with 7: 1029 ohms.Reference 1 0: 803 ohms 2: 962 ohms 3: 806 ohms 4: >10k ohms 5: 842 ohms 6: 985 ohms 7: 1259 ohms reference 2 with 0: 797 ohms, with 1: 962 ohms, with 3: 809 ohms, with 4: >10 ohms, with 5: 912 ohms, with 6: 910 ohms, and with 7: 1235 ohms.The battery level w as reported to be 3.135v.It was reported thatthere was a short circuit.There were no patient symptoms reported.

Event Description

Additional information was received from the manufacturing representative indicating that reprogramming the patient was performed to resolve the eri issue.They also noted that the cause of the impedance issues on electrode 4 were not determined.

Manufacturer Narrative

Information from mdr #3007566237-2016-03677 applies to this event.Any additional information regarding the event, will be reported in this mdr instead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturer representative reported that there was a short circuit.No patient symptoms reported.Additional information received the manufacturer representative on 2016-11-30 reported that the manufacturer representative had received information on steps to take from their call to technical services.It was reported that the issues resolved when the patient was reprogrammed around the short circuit and the battery went back to the proper voltage.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6016437
• MDR Text Key: 56929197
• Report Number: 3004209178-2016-21472
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Date Device Manufactured: 02/08/2016
• 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: 89 YR